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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Changes in FMISO parameters (HV and T:Bmax)

Outcome Description:

ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

Outcome Time Frame:

Baseline and up to 2 years

Safety Issue:

No

Principal Investigator

Janet Eary

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01442

NCT ID:

NCT01169350

Start Date:

February 2010

Completion Date:

Related Keywords:

  • 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
  • Sarcoma

Name

Location

University of Washington Medical CenterSeattle, Washington  98195-6043
Seattle Cancer Care AllianceSeattle, Washington  98109