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Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Primary Purpose

Cervical Cancer, Endometrial Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-Fluorodeoxyglucose (18F-FDG)
PET/CT imaging
PET/MRI imaging
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring 18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222

Eligibility Criteria

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

Inclusion Criteria:

  • The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:

    • Uterine serous carcinoma
    • Clear cell endometrial carcinoma
    • Grade 3 endometrioid carcinoma
    • Endometrial carcinosarcoma
    • Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 > 35 U/ml.
  • Age ≥18 years
  • Hemoglobin ≥10 g/dL
  • Plasma albumin ≥3 g/dL
  • GOG performance status ≤2
  • Plasma glucose ≤200 mg/dL
  • Plasma creatinine ≤1.6
  • Well-controlled hypertension
  • Medical clearance for surgery and considered an appropriate surgical candidate
  • Negative serum pregnancy test, if of child-bearing potential
  • If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
  • Participation in other research protocols does not exclude a patient from participation in this study

Exclusion Criteria:

  • Hemoglobin <10 g/dL
  • Plasma albumin <3 g/dL
  • GOG performance status >2
  • Plasma glucose >200 mg/dL
  • Renal insufficiency with plasma creatinine >1.6
  • Uncontrolled hypertension
  • Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate
  • Pregnancy

For Stage 2:

  • Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
  • Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent only)
  • Memorial Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Bergen (Consent only)
  • Memorial Sloan Kettering Commack (Consent only)
  • Memorial Sloan Kettering Westchester (Consent only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau (Consent only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intracervical 18F-FDG injection during a dynamic PET/CT

Arm Description

The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.

Outcomes

Primary Outcome Measures

diagnostic accuracy of Positron Lymphography
Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.

Secondary Outcome Measures

to evaluate several standard uptake value (SUV) (18F-FDG avidity)
will assess the ability of SUV to predict malignant disease. The continuous variable of SUV assigned to a given lymph node during Positron Lymphography will be compared with the pathologic assessment (benign vs malignant) of each labelled lymph node. The SUV assigned to a given lymph node is done using the the imaging software and not up to the discretion of the radiologist.

Full Information

First Posted
November 4, 2014
Last Updated
July 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02285192
Brief Title
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Official Title
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer
Keywords
18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
intracervical 18F-FDG injection during a dynamic PET/CT
Arm Type
Experimental
Arm Description
The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.
Intervention Type
Radiation
Intervention Name(s)
18F-Fluorodeoxyglucose (18F-FDG)
Intervention Type
Device
Intervention Name(s)
PET/CT imaging
Intervention Type
Device
Intervention Name(s)
PET/MRI imaging
Primary Outcome Measure Information:
Title
diagnostic accuracy of Positron Lymphography
Description
Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
to evaluate several standard uptake value (SUV) (18F-FDG avidity)
Description
will assess the ability of SUV to predict malignant disease. The continuous variable of SUV assigned to a given lymph node during Positron Lymphography will be compared with the pathologic assessment (benign vs malignant) of each labelled lymph node. The SUV assigned to a given lymph node is done using the the imaging software and not up to the discretion of the radiologist.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following: Uterine serous carcinoma Clear cell endometrial carcinoma Grade 3 endometrioid carcinoma Endometrial carcinosarcoma Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 > 35 U/ml. Age ≥18 years Hemoglobin ≥10 g/dL Plasma albumin ≥3 g/dL GOG performance status ≤2 Plasma glucose ≤200 mg/dL Plasma creatinine ≤1.6 Well-controlled hypertension Medical clearance for surgery and considered an appropriate surgical candidate Negative serum pregnancy test, if of child-bearing potential If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease Participation in other research protocols does not exclude a patient from participation in this study Exclusion Criteria: Hemoglobin <10 g/dL Plasma albumin <3 g/dL GOG performance status >2 Plasma glucose >200 mg/dL Renal insufficiency with plasma creatinine >1.6 Uncontrolled hypertension Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate Pregnancy For Stage 2: Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc. Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mueller, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

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