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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: [18F]FLT-PET/CT Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: [18F]FLT-PET/CT
Dose of 0.07 mCi/Kg [18F]FLT to max of 5 mCi (± 20%) will be given intravenously.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905538


Contacts
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Contact: Laura Klesse, MD, PhD 214--648-3896 Laura.Klesse@UTSouthwestern.edu

Locations
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United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Laura Klesse, MD, PhD         
Sponsors and Collaborators
Laura Klesse
Investigators
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Principal Investigator: Laura Klesse, MD, PhD University of Texas Southwestern Medical Center
More Information
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Responsible Party: Laura Klesse, Associate Professor of Pediatrics Hematology/Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03905538    
Other Study ID Numbers: STU-2019-0627
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms