The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").
Primary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment tumor necrosis in newly-diagnosed and treated osteosarcoma patients. Secondary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment pain reduction in newly-diagnosed and treated osteosarcoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
Stanford University
Stanford, California, United States
Detection of Tumor Necrosis Post-chemotherapy
Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. The ability of 18F FTC 146 PET/CT to evaluate treatment effect will be assessed as the percentage of tumor that is assessed as necrotic after the treatment course. The outcome will be reported as the mean percentage of the resected tumor (removed by surgery) that is assessed by histopathology as necrotic, with standard deviation.
Time frame: 12 weeks
Maximum Standardized Uptake Value (SUVmax)
Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. Based on the PET/CT scans, the maximum standardized uptake value (SUVmax) in the tumor region of interest (ROI) will be calculated at baseline and after treatment. The outcome will be reported as the mean percent change in SUVmax from baseline to post treatment, with standard deviation.
Time frame: 12 weeks
Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect
Participants will receive neoadjuvant (pre surgery) chemotherapy, nominally three 3 week cycles administered over up to 12 weeks. The treatment effect of the neoadjuvant chemotherapy will be assessed as the change in scores on the PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire, from baseline to post treatment. The result will be reported as the mean difference from baseline to post treatment, with standard deviation.
Time frame: 12 weeks
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