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PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biopsy
computed tomography
positron emission tomography
fludeoxyglucose F 18
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring stage I cervical cancer, stage II cervical cancer, recurrent cervical cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Must meet one of the following criteria: Histologically confirmed primary invasive squamous carcinoma or adenocarcinoma of the cervix History of cervical cancer suspected of being recurrent Known diagnosis of recurrent cervical cancer being considered for pelvic exenteration PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No insulin-dependent diabetes mellitus No active serious infection not controlled by antibiotics Must tolerate being in the scanner for the duration of the study Not mentally retarded No prisoners Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 17, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003429
Brief Title
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
Official Title
A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the ability to detect cancer or recurrence of cancer. PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.
Detailed Description
OBJECTIVES: Assess the feasibility of using fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in patients with primary or recurrent cervical cancer. Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients. Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers. Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer. Investigate the ability of FDG-PET to identify recurrent cervical cancer. OUTLINE: This is a diagnostic study. Patients with primary cervical cancer receive fludeoxyglucose F 18 (FDG) intravenously followed 45 minutes later with positron emission tomography (PET) imaging over 60 minutes, as well as computed tomography (CT) scan. Both diagnostic imaging techniques are to assess the abdomen and pelvis, and must be done within 2 weeks prior to surgery. Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings. Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax, abdomen, and pelvis prior to surgical exploration for pelvic exenteration. All biopsy specimens are evaluated for correlation with diagnostic tests findings. PROJECTED ACCRUAL: A total of 30 patients (20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage I cervical cancer, stage II cervical cancer, recurrent cervical cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Must meet one of the following criteria: Histologically confirmed primary invasive squamous carcinoma or adenocarcinoma of the cervix History of cervical cancer suspected of being recurrent Known diagnosis of recurrent cervical cancer being considered for pelvic exenteration PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No insulin-dependent diabetes mellitus No active serious infection not controlled by antibiotics Must tolerate being in the scanner for the duration of the study Not mentally retarded No prisoners Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Larson, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

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