[18F]FLT PET / CT in Predicting Tumor Response to Chemotherapy in Pediatric Patients with Solid Tumors

Status: Active

Description

This trial studies how well [18F] FLT positron emission tomography (PET) / computed tomography (CT) works in predicting tumor response to chemotherapy in pediatric patients with solid tumors. Diagnostic procedures, such as [18F]FLT PET / CT, may measure dividing (or growing) cells in the tumor and may help predict whether the tumor will progress after therapy.

Eligibility 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.
  • 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).

Locations & Contacts

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Laura J. Klesse
Phone: 214-648-2912
Email: Laura.Klesse@UTSouthwestern.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess if percentage change in fluorothymidine F-18 ([18F]FLT) PET/CT quantitative parameters (standardized uptake value [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:

I. 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.

II. 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.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) and undergo PET/CT scan over 20-30 minutes before beginning chemotherapy and after second cycle but before third cycle of chemotherapy.

After completion of study, patients are followed up for 2 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
UT Southwestern / Simmons Cancer Center-Dallas

Principal Investigator
Laura J. Klesse

Trial IDs

Primary ID STU-2019-0627; SCCC-06Y19
Secondary IDs NCI-2019-02579
Clinicaltrials.gov ID NCT03905538