Positron Emission Tomography Using Fluoromisonidazole F 18 and Fludeoxyglucose F 18 to Find Oxygen in Tumor Cells of Patients Undergoing Treatment for Newly Diagnosed Stage IB, Stage II, Stage III, or Stage IV Cervical Cancer

PRIMARY OBJECTIVES:

I. Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival
of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.

SECONDARY OBJECTIVES:

I. Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and
that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).

II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients
receiving radiotherapy.

III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume
of the primary tumor estimated by CT scan.

IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients
on sequential days in a test-retest protocol.

V. Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test
whether [^18F] FMISO is an independent predictor of treatment outcome.

OUTLINE:

Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET
scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have
not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical
management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two
[^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of
this imaging measurement.

Patients response to therapy is followed periodically until time to disease progression or
for 2 years.

Inclusion Criteria:

- Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix

- Clinical stage IB-IVB by FIGO criteria

- Size of the primary tumor ≥ 2 cm as assessed by CT scan

- Measurable disease

- Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management

- No prior cervical cancer diagnosis

- No known brain metastases

- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)

- Life expectancy > 12 months

- Not pregnant

- No nursing for 24 hours after fluoromisonidazole F 18 ([^18F] FMISO) PET scanning

- Negative pregnancy test

- Weight ≤ 400 lbs

- Sufficiently healthy to undergo cancer treatment

- Willing to undergo PET scanning with urinary bladder catheterization

- Leukocytes ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin normal

- AST/ALT ≤ 2.5 times normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- No serious medical co-morbidities that would preclude definitive local therapy

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to [^18F] FMISO

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements.

- No prior surgery or radiotherapy for cervical cancer

- Other concurrent investigational agents allowed