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

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ClinicalTrials.gov Identifier: NCT03905538
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Laura Klesse, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE April 5, 2019
Last Update Posted Date August 4, 2022
Actual Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Correlation between change in [18F]FLT PET/CT and progression free and overall survival [ Time Frame: up to 24 months following treatment ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
Official Title  ICMJE Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: [18F]FLT-PET/CT
Dose of 0.07 mCi/Kg [18F]FLT to max of 5 mCi (± 20%) will be given intravenously.
Study Arms  ICMJE Experimental: [18F]FLT-PET/CT Arm
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.
Intervention: Drug: [18F]FLT-PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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.

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Klesse, MD, PhD 214--648-3896 Laura.Klesse@UTSouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03905538
Other Study ID Numbers  ICMJE STU-2019-0627
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Laura Klesse, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Laura Klesse
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Klesse, MD, PhD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP