FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00559377

Run by

National Cancer Institute (NCI)

People needed

16

Starts

2007-11-01

Expected to finish

2014-05-01

Last updated by the study team

2016-12-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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