FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Squamous Cell Carcinoma; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Hypoxia
Intervention: 18F-fluoromisonidazole; fluorodeoxyglucose F 18; positron emission tomography; tissue oxygen measurement
Intervention description: Undergo ^18F FMISO PET scan; Undergo ^18F FDG PET scan; Undergo ^18F-FMISO and ^18F FDG PET scan; Undergo ^18 F FMISO PET and ^18F FDG PET
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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