Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03905538|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: [18F]FLT-PET/CT||Early Phase 1|
Primary Objective is 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 progression free survival at 1 and 2 years in pediatric patients with newly diagnosed solid tumors.
Secondary Objectives are: (1) 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 solid tumors; and (2) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: [18F]FLT-PET/CT Arm
The experimental [18F]FLT-PET/CT will be completed before initiation of chemotherapy and prior to the third cycle (or month) of chemotherapy. Laboratory analysis and correlative radiology, as directed per clinical care based on the primary diagnosis, are required within 30 days of the baseline [18F]FLT PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Dose of 0.07 mCi/Kg [18F]FLT to max of 5 mCi (± 20%) will be given intravenously.
- Correlation between change in [18F]FLT PET/CT and progression free and overall survival [ Time Frame: up to 24 months following treatment ]Determine that a positive response (decrease in quantitative parameters) at an interim [18F]FLT PET/CT is related to progression free survival and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905538
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Laura Klesse, MD, PhD||University of Texas Southwestern Medical Center|