FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage IVA Cervical Cancer; Stage III Cervical Cancer; Cervical Adenocarcinoma; Stage IB Cervical Cancer; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Cervical Squamous Cell Carcinoma; Stage IVB Cervical Cancer

Treatments: Radiation: fluorodeoxyglucose F 18; Procedure: positron emission tomography; Other: tissue oxygen measurement; Other: 18F-fluoromisonidazole

Study type: Interventional

Funder types: NIH

Identifiers

NCT00559377

UW IRB# 6143 (Other Identifier)

7958

N01CM37008 (Other Identifier)

NCI-2009-00257 (Registry Identifier)

Details and patient eligibility

About

This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.

Full description

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Diagnostic FMISO AND FDG PET

Experimental group

Description:

Patients receive \^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 \^18F FDG PET scan as part of their routine clinical management undergo \^18F FDG PET scanning at baseline.

Treatment:

Other: tissue oxygen measurement

Other: 18F-fluoromisonidazole

Procedure: positron emission tomography

Radiation: fluorodeoxyglucose F 18