TheranosticTrials.org

Clinical Trial · NCT00559377

FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

Overview

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.

Sponsor

National Cancer Institute

Phase

Phase 2

Contacts

Joseph Rajendran (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00559377

Drug / Compound

fluoromisonidazole

Isotope(s):
Target(s):
  • Hypoxia
Ligand Class: Small Molecules

fludeoxyglucose

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Negative pregnancy test
  • Not pregnant
  • Platelet count ≥ 100,000/mm³
  • Unstable angina pectoris
  • No concurrent uncontrolled illness including, but not limited to, any of the following:
  • No prior cervical cancer diagnosis
  • No nursing for 24 hours after fluoromisonidazole F 18 (\[\^18F\] FMISO) PET scanning
  • No serious medical co-morbidities that would preclude definitive local therapy
  • Sufficiently healthy to undergo cancer treatment
  • Measurable disease
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Ongoing or active infection
  • ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
  • Weight ≤ 400 lbs
  • AST/ALT ≤ 2.5 times normal
  • Leukocytes ≥ 3,000/mm³
  • Symptomatic congestive heart failure
  • Clinical stage IB-IVB by FIGO criteria
  • No known brain metastases
  • Willing to undergo PET scanning with urinary bladder catheterization
  • Cardiac arrhythmia
  • Total bilirubin normal
  • Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to \[\^18F\] FMISO
  • Size of the primary tumor ≥ 2 cm as assessed by CT scan
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • No prior surgery or radiotherapy for cervical cancer
  • Other concurrent investigational agents allowed
  • Absolute neutrophil count ≥ 1,500/mm³
  • Life expectancy \> 12 months

Exclusion

Exclusion criteria not yet provided.