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

NCT03905538 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[18F]FLT-PET/CT

Dose of 0.07 mCi/Kg \[18F\]FLT to max of 5 mCi (± 20%) will be given intravenously.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Laura Klesse, MD, PhD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905538 on ClinicalTrials.gov