This trial studies how well [18F] FLT positron emission tomography (PET)/computed tomography (CT) works in predicting tumor response to chemotherapy in pediatric patients with solid tumors. Diagnostic procedures, such as [18F]FLT PET/CT, may measure dividing (or growing) cells in the tumor and may help predict whether the tumor will progress after therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03905538.
PRIMARY OBJECTIVES:
I. To assess if percentage change in fluorothymidine F-18 ([18F]FLT) PET/CT quantitative parameters (standardized uptake value [SUV] max, or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict progression free survival at 1 and 2 years in pediatric patients with newly diagnosed with newly diagnosed or relapsed solid tumors.
SECONDARY OBJECTIVES:
I. To assess if percentage change in [18F]FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict overall survival at 2 years in pediatric patients with newly diagnosed or relapsed solid tumors.
II. For enrolled patients that undergo tumor resection as part of their therapy regimen within one month of the FLT imaging, mitotic index of the tumor will be assessed as compared to initial biopsy specimen and correlate with FLT activity.
OUTLINE:
Patients receive fluorothymidine F-18 intravenously (IV) and undergo PET/CT scan over 20-30 minutes before beginning chemotherapy and after second cycle but before third cycle of chemotherapy.
After completion of study, patients are followed up for 2 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorLaura J. Klesse