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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

Conditions: Stage II Adult Soft Tissue Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma

Treatments: Other: laboratory biomarker analysis; Procedure: positron emission tomography; Other: 18F-fluoromisonidazole; Procedure: computed tomography; Radiation: fludeoxyglucose F 18

Study type: Interventional

Funder types: NIH

Identifiers

NCT01169350

NCI-2011-01442 (Registry Identifier)

6971 (Other Identifier)

UW-8468

CDR0000665359

8468

N01CM37008-9-0-0 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Diagnostic (18F FDG and 18F FMISO PET/CT)

Experimental group

Description:

Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

Treatment:

Procedure: positron emission tomography

Other: laboratory biomarker analysis

Procedure: computed tomography

Radiation: fludeoxyglucose F 18

Other: 18F-fluoromisonidazole