Clinical Trial · NCT01169350

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

Overview

This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.

Sponsor

National Cancer Institute

Phase

Phase 2

Contacts

Janet Eary (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01169350

Drug / Compound

fludeoxyglucose

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

fluoromisonidazole

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

Eligibility

Inclusion

Tumor size ≥ 2 cm
Life expectancy ≥ 12 months
Histologically confirmed intermediate- or high-grade soft tissue sarcoma
Negative pregnancy test
Able to lie on the imaging table for up to 1.5 hours
Willing to undergo PET scanning
Biopsy proven or highly suspicious primary or recurrent disease
Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
Weight ≤ 400 lbs
Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)

Exclusion

Exclusion criteria not yet provided.