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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 : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Klesse, University of Texas Southwestern Medical Center

Brief 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.

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 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 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.


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Study Type : Interventional
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

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.




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



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Ages Eligible for Study:   13 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.
  • 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)

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 Not yet 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

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Responsible Party: Laura Klesse, Associate Professor of Pediatrics Hematology/Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03905538     History of Changes
Other Study ID Numbers: STU-2019-0627
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No