NCT03905538

Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The experimental \[18F\]FLT-PET/CT will be completed before initiation of chemotherapy at either diagnosis or initiation of salvage chemotherapy at relapse 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.

Detailed description

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 or relapsed 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 or relapsed 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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	[18F]FLT-PET/CT	Dose of 0.07 mCi/Kg \[18F\]FLT to max of 5 mCi (± 20%) will be given intravenously.

Timeline

• Start date: 2019-08-13
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2019-04-05
• Last updated: 2024-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study