This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in diagnosing patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03613259.
PRIMARY OBJECTIVE:
I. To determine fluorothymidine F-18 (18F-FLT) uptake parameters before and after radiotherapy.
SECONDARY OBJECTIVES:
I. To correlate 18F-FLT uptake post-radiotherapy scan with pathologic response.
II. To correlate levels the mitotic index in surgical specimens with the 18F-FLT uptake in post-radiation scans.
III. To correlate 18F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.
EXPLORATORY OBJECTIVES:
I. To compare 18F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both.
II. To compare 18F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation.
OUTLINE:
Patients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
After completion of study, patients are followed up for 3 years.
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorArthur Y. Hung