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A Pilot Study Evaluating in Vivo PARP-1 Expression with18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Glioblastoma
The subject will be a candidate for this imaging study because they have agreed to participate in a treatment study involving TTFields (Optune device), a device that uses low intensity, wave like electrical fields, and a PARP inhibitor drug (niraparib). The research study is being conducted to test how a new radioactive imaging drug called 18F-Fluorthanatrace (18F-FTT) can be used to image sites of recurrent brain cancer before or after new treatment or surgery. 18F-FTT is a drug used with an imaging test called Positron Emission Tomography/Computed Tomography (PET/CT).
Participants will undergo up to three \[18F\]FTT PET/CT scans at the following time points: * Baseline: Subjects from either cohort may agree to undergo a baseline \[18F\]FTT PET/CT prior to the start of TTFields therapy to measure baseline FTT uptake. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability. * Post-TTFields: Subjects from both cohorts will undergo an \[18F\]FTT PET/CT scan 3-7 days after initiation of TTFields therapy and before surgical resection or initiation of niraparib. This scan will measure the FTT uptake after TTFields therapy is initiated. This scan is required. * Post-PARPi: Subjects from Cohort A may agree to undergo an post-therapy \[18F\]FTT PET/CT scan 1- 21 days after the initiation of niraparib to collect pilot data on the changes in FTT uptake after TTFields and niraparib combination therapy. This scan is not required and may be omitted at the discretion of the investigator or based on subject availability. For each \[18F\]FTT PET/CT imaging session, participants will undergo approximately 60 minutes of dynamic brain scanning starting nearly simultaneously with the injection of \[18F\]FTT. A second optional brain scan will be done at approximately 90 minutes post-injection. Each imaging session will include an injection of up to 12 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of \[18F\]FTT.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
February 20, 2020
Primary Completion Date
June 10, 2024
Completion Date
June 10, 2024
Last Updated
June 17, 2024
3
ACTUAL participants
18F-FluorThanatrace
DRUG
Lead Sponsor
University of Pennsylvania
NCT05839379
NCT06860594
Data Source & Attribution
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