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

NCT03905538 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: STU-2019-0627
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Correlation between change in [18F]FLT PET/CT and progression free and overall survival

  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

  up to 24 months following treatment

Study Arms (1)

[18F]FLT-PET/CT Arm

EXPERIMENTAL

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.

Drug: [18F]FLT-PET/CT

Interventions

[18F]FLT-PET/CT DRUG

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

[18F]FLT-PET/CT Arm

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with histologically confirmed solid tumor malignancies with residual tumors present that require standard of care chemotherapy for a minimum number of cycles. All anatomical sites and all tumor histologies are eligible including central nervous system tumors. Both newly diagnosed and/or newly relapsed patients are eligible.
• Patients ages 8 - 25 years
• In the opinion of the investigator, patients must be thought to be able to lie still for imaging without sedation for 20 - 30 minutes.
• Patients must have a performance status of \> 50% (Lansky or Karnofsky).
• Patients of childbearing potential must have a negative urine or serum pregnancy test as per institution's standard of care within 7 days prior to \[18F\]FLT PET/CT imaging.
• Ability to understand and the willingness to sign a written informed consent/assent.

You may not qualify if:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to \[18F\]FLT
• Newly diagnosed subjects who had prior chemotherapy or radiotherapy before enrollment in the study. Relapsed patients are eligible prior to starting their relapsed chemotherapy regimen if they meet the other eligibility criteria.
• Subjects for whom chemotherapy is not a standard of care primary therapy option.
• Patients who are pregnant or breast-feeding.
• Patients with no residual tumor (i.e. complete resection at diagnosis or relapse).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Study Officials

• Laura Klesse, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics Hematology/Oncology

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: April 5, 2019
• Study Start: August 13, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

US (1)