NCT01169350

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Adult Soft Tissue Sarcoma
• Stage I Adult Soft Tissue Sarcoma
• Stage II Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
RADIATION	fludeoxyglucose F 18	Undergo 18F FDG and 18F FMISO PET/CT scans
OTHER	18F-fluoromisonidazole	Undergo 18F FDG and 18F FMISO PET/CT scans
PROCEDURE	positron emission tomography	Undergo 18F FDG and 18F FMISO PET/CT scans
PROCEDURE	computed tomography	Undergo 18F FDG and 18F FMISO PET/CT scans
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-10-01
• Completion: 2013-08-01
• First posted: 2010-07-26
• Last updated: 2017-11-17
• Results posted: 2017-11-17

Locations

2 sites across 1 country: United States