This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging 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.
PRIMARY OBJECTIVES: 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. TERTIARY 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 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.
Measured by mean SUV where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.
Time frame: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Change in Fluorothymidine F-18 peak SUV as response to therapy
Measured by peak SUV value where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.
Time frame: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Fluorothymidine F-18 mean SUV correlation with pathology mitotic index
Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
Time frame: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Fluorothymidine F-18 peak SUV correlation with pathology mitotic index
Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
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Time frame: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Fluorothymidine F-18 peak SUV correlation with enhancement by MRI
Measured as Ki-67. Evaluated by the standard of care magnetic resonance imaging. Will assess the size and location of irregularly increased T2-weighted signal intensity. Descriptive statistical analysis will be conducted
Time frame: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
Volume of T2 enhanced MRI
Measured in (cm3).
Time frame: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography