Clinical trial NCT01169350: 18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-07-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: Changes From Baseline Hypoxic Volume (HV)
timeFrame: Baseline and up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 2 years
measure: Disease Free Survival
timeFrame: From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years
measure: Response to Radiation Therapy (XRT) by RECIST Criteria
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Janet Eary
role: PRINCIPAL_INVESTIGATOR
References: