PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
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.
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer|
|Study Start Date:||May 1998|
|Study Completion Date:||October 2002|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003429
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven M. Larson, MD||Memorial Sloan Kettering Cancer Center|