A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
18 Years
N/A
Female
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
Trial Information
A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Overall survival (OS)
Outcome Description:
The first analysis will evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables. Multivariate Cox regression (Kalbfleisch 1980) will be used to analyze OS.
Outcome Time Frame:
For up to 2 years
Safety Issue:
No
Principal Investigator
Joseph Rajendran
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Washington
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00257
NCT ID:
NCT00559377
Start Date:
November 2007
Completion Date:
Related Keywords:
- 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
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma
- Carcinoma, Squamous Cell
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
