18F-FluorThanatrace (PET/CT) in Glioblastoma

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Glioblastoma

Clinical Trial Details

NCT number	NCT04221061
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Terminated
Phase	Early Phase 1
Start date	February 20, 2020
Completion date	June 10, 2024

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