18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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 measurement.

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.

Inclusion Criteria:

- Histologically confirmed intermediate- or high-grade soft tissue sarcoma

- Biopsy proven or highly suspicious primary or recurrent disease

- Tumor size ≥ 2 cm

- Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy

- Life expectancy ≥ 12 months

- Negative pregnancy test

- Willing to undergo PET scanning

- Willing to undergo possible urinary bladder catheterization (for patients with pelvic
or proximal thigh tumors)

- Able to lie on the imaging table for up to 1.5 hours

- Weight ≤ 400 lbs

- Not pregnant