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A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Steven M. Larson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066454

NCT ID:

NCT00003429

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage I cervical cancer
  • stage II cervical cancer
  • recurrent cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021