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18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Scans in Assessing Oxygen in Tumor Tissue of Patients With Soft Tissue Sarcoma Undergoing Chemotherapy With or Without Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01169350
First received: July 23, 2010
Last updated: February 19, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
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
 Radiation: fludeoxyglucose F 18
Other: 18F-fluoromisonidazole
Procedure: positron emission tomography
Procedure: computed tomography
Other: laboratory biomarker analysis
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Changes in FMISO parameters (HV and T:Bmax) [ Time Frame: Baseline and up to 2 years ] [ Designated as safety issue: No ]
    ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.

  • Disease free survival [ Time Frame: From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years ] [ Designated as safety issue: No ]
    Multivariate Cox regression will be used.

  • Response to XRT by RECIST criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be approached using multivariate logistic regression.


Estimated Enrollment: 40
Study Start Date: February 2010
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (18F FDG and 18F FMISO PET/CT)
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.
 Radiation: fludeoxyglucose F 18
Undergo 18F FDG and 18F FMISO PET/CT scans
Other Names:
  • 18FDG
  • FDG
Other: 18F-fluoromisonidazole
Undergo 18F FDG and 18F FMISO PET/CT scans
Other Name: 18F-FMISO
Procedure: positron emission tomography
Undergo 18F FDG and 18F FMISO PET/CT scans
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo 18F FDG and 18F FMISO PET/CT scans
Other Name: tomography, computed
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169350

Locations
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Janet Eary University of Washington
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01169350     History of Changes
Other Study ID Numbers: NCI-2011-01442, N01CM37008, 6971
Study First Received: July 23, 2010
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Fluoromisonidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013