A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Soft Tissue Sarcoma
I. Evaluate the potential of 18F-fluoromisonidazole ([18F] FMISO) as a non-invasive
indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue
markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant
chemotherapy with or without radiotherapy.
I. Test [18F] FMISO tumor uptake as an independent predictor of patient outcome and if it
provides additional predictive power over fludeoxyglucose F 18 PET scan.
II. Test [18F] FMISO tumor uptake as a predictor of response in the subgroup of patients
treated with radiotherapy and chemotherapy.
III. Test the reproducibility of [18F] FMISO uptake in tumors by imaging the same patients
on sequential days in a test-retest protocol.
IV. Determine the relationship between hypoxia-related biomarkers (HIF1-a and VEGF),
proliferation biomarkers (microvascular density, p53, and Ki-67), and regional [18F] FMISO
uptake in tumor.
Patients undergo fludeoxyglucose F 18 [18F] FDG and 18F-fluoromisonidazole ([18F] FMISO)
positron emission tomography (PET)/CT scans before starting neoadjuvant chemotherapy
(without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
NOTE: Some patients may undergo repeat [18F] FMISO PET/CT scan within 48 hours after the
first [18F] FMISO scan to evaluate the variability (test-retest) of this imaging
Blood samples are collected after completion of [18F] FMISO and [18F] FDG PET/CT scans for
laboratory biomarker studies by IHC assays. Tumor samples from biopsy or surgery are also
collected for biomarker studies.
After completion of study procedures, patients are followed up periodically for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Changes in FMISO parameters (HV and T:Bmax)
ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.
Baseline and up to 2 years
University of Washington
United States: Food and Drug Administration
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|