18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT01169350|
Recruitment Status : Terminated (funding source ended earlier than anticipated)
First Posted : July 26, 2010
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||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|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||August 2013|
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 scansOther: 18F-fluoromisonidazole
Undergo 18F FDG and 18F FMISO PET/CT scansProcedure: positron emission tomography
Undergo 18F FDG and 18F FMISO PET/CT scansProcedure: computed tomography
Undergo 18F FDG and 18F FMISO PET/CT scansOther: laboratory biomarker analysis
- Changes From Baseline Hypoxic Volume (HV) [ Time Frame: Baseline and up to 2 years ]ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.
- Overall Survival [ Time Frame: Up to 2 years ]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 ]Multivariate Cox regression will be used.
- Response to Radiation Therapy (XRT) by RECIST Criteria [ Time Frame: Up to 2 years ]Will be approached using multivariate logistic regression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169350
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Janet Eary||University of Washington|