PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
NCT ID: NCT00003429
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1998-05-31
2002-10-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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biopsy
computed tomography
positron emission tomography
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Steven M. Larson, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-98047
Identifier Type: -
Identifier Source: secondary_id
NCI-G98-1452
Identifier Type: -
Identifier Source: secondary_id
98-047
Identifier Type: -
Identifier Source: org_study_id