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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laura Klesse

Criteria

Inclusion Criteria:

• 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.

• Patients ages 13 - 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.

Exclusion Criteria:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to [18F]FLT

• Subjects who had prior chemotherapy or radiotherapy before enrollment in the study.

• 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)