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Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
fludeoxyglucose F 18
positron emission tomography
computed tomography
ferumoxtran-10
magnetic resonance imaging
diagnostic lymphadenectomy
lymph node biopsy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Invasive carcinoma of the cervix meeting all of the following criteria:

      • Previously untreated, primary disease
      • Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease
      • Any cell type allowed
    • High-risk endometrial carcinoma meeting 1 of the following criteria:

      • Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
      • Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
  • Under consideration for chemoradiotherapy (patients with cervical cancer)
  • Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
  • Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling

    • No surgery for patients with advanced lymphadenopathy
  • No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
  • No known metastases to the lungs or scalene lymph nodes
  • No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis

    • Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
  • Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
  • GOG performance status 0-2
  • Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
  • Ferritin levels =< 600 ng/mL OR saturation of transferrin level =< 50%

    • Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload
  • Not pregnant or nursing
  • Negative pregnancy test
  • No patients weighing greater than that allowable by the PET/CT scanner
  • No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy
  • No history of anaphylactic or life-threatening allergic reactions to any contrast media
  • No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer
  • No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
  • No immunodeficiencies that would predispose patient to specific or nonspecific mediator release
  • No history of cirrhosis
  • No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)
  • No prior pelvic or abdominal lymphadenectomy
  • No prior pelvic radiotherapy
  • No prior anticancer therapy that would contraindicate study participation
  • No ferumoxides within the past 2 weeks
  • No investigational agents within the past 30 days
  • No other concurrent investigational agents

Sites / Locations

  • Jonsson Comprehensive Cancer Center
  • University of California at Los Angeles Health System
  • Olive View-University of California Los Angeles Medical Center
  • The Hospital of Central Connecticut
  • Sarasota Memorial Hospital
  • Georgia Regents University Medical Center
  • Massachusetts General Hospital Cancer Center
  • Wayne State University/Karmanos Cancer Institute
  • Mayo Clinic
  • UMDNJ - New Jersey Medical School
  • Island Gynecologic Oncology
  • Montefiore Medical Center-Einstein Campus
  • Mount Sinai Medical Center
  • Weill Medical College of Cornell University
  • Carolinas Medical Center
  • University of Cincinnati
  • Case Western Reserve University
  • University of Oklahoma Health Sciences Center
  • Providence Cancer Center -The Plaza
  • Providence Portland Medical Center
  • Fox Chase Cancer Center
  • Women and Infants Hospital
  • Vanderbilt-Ingram Cancer Center
  • Brooke Army Medical Center
  • CHUQ - Pavilion Hotel-Dieu de Quebec
  • Hokkaido University Hospital
  • Kagoshima City Hospital
  • Saitama Medical University International Medical Center
  • Keimyung University-Dongsan Medical Center
  • Seoul National University Hospital
  • Gangnam Severance Hospital
  • Asan Medical Center
  • Korea Cancer Center Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

Arm Description

Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.

Outcomes

Primary Outcome Measures

The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.

Secondary Outcome Measures

The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Number of cervical cancer patients with reasons of interruption in radiation therapy

Full Information

First Posted
December 27, 2006
Last Updated
July 19, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00416455
Brief Title
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
Official Title
Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
July 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NRG Oncology

4. Oversight

5. Study Description

Brief Summary
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma. II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer. SECONDARY OBJECTIVES: I. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer. II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients. III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients. IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients. V. Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning. VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer. VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer. VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer. IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer. X. Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients. OUTLINE: This is a multicenter study. Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan. After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage IVA Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (diagnostic scans, surgery, chemotherapy, radiation)
Arm Type
Experimental
Arm Description
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
18FDG, FDG
Intervention Description
Undergo FDG PET/CT
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo FDG PET/CT
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo FDG PET/CT
Intervention Type
Drug
Intervention Name(s)
ferumoxtran-10
Other Intervention Name(s)
AMI-227, Combidex, G-53425, Sinerem, USPIO
Intervention Description
Undergo femoxtran-10 MRI
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo femoxtran-10 MRI
Intervention Type
Procedure
Intervention Name(s)
diagnostic lymphadenectomy
Intervention Description
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
lymph node biopsy
Other Intervention Name(s)
Biopsy of Lymph Node
Intervention Description
Undergo pelvic and abdominal lymph node biopsy
Primary Outcome Measure Information:
Title
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET-CT) and after surgery (pathology)
Title
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Description
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Secondary Outcome Measure Information:
Title
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
Time Frame
Before surgery (DCT) and after surgery (pathology)
Title
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Description
The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Description
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Description
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Description
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Description
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Description
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Time Frame
Before surgery (FDG-PET/CT) and after surgery (pathology)
Title
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Description
Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Time Frame
During surgery and up to 30 days after surgery.
Title
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Description
Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Time Frame
Within 4 weeks from PET/CT
Title
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Description
Number of cervical cancer patients with reasons of interruption in radiation therapy
Time Frame
Within 6 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of 1 of the following: Invasive carcinoma of the cervix meeting all of the following criteria: Previously untreated, primary disease Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease Any cell type allowed High-risk endometrial carcinoma meeting 1 of the following criteria: Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage Under consideration for chemoradiotherapy (patients with cervical cancer) Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling No surgery for patients with advanced lymphadenopathy No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment No known metastases to the lungs or scalene lymph nodes No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG) GOG performance status 0-2 Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol Ferritin levels =< 600 ng/mL OR saturation of transferrin level =< 50% Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload Not pregnant or nursing Negative pregnancy test No patients weighing greater than that allowable by the PET/CT scanner No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy No history of anaphylactic or life-threatening allergic reactions to any contrast media No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI) No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations) No immunodeficiencies that would predispose patient to specific or nonspecific mediator release No history of cirrhosis No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL) No prior pelvic or abdominal lymphadenectomy No prior pelvic radiotherapy No prior anticancer therapy that would contraindicate study participation No ferumoxides within the past 2 weeks No investigational agents within the past 30 days No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Atri
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California at Los Angeles Health System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Olive View-University of California Los Angeles Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Georgia Regents University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UMDNJ - New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Island Gynecologic Oncology
City
Brightwaters
State/Province
New York
ZIP/Postal Code
11718
Country
United States
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Cancer Center -The Plaza
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
CHUQ - Pavilion Hotel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kagoshima City Hospital
City
Kagoshima City, Kagoshima
ZIP/Postal Code
892-8580
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Keimyung University-Dongsan Medical Center
City
Jung-Ku
State/Province
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

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