This early phase I trial studies how well an [18F]FTT positron emission tomography (PET)/computed tomography (CT) scan works in evaluating PARP-1 expression in patients with glioblastoma that has come back (recurrent) who are undergoing tumor treating fields (TTFields) therapy. PARP-1 is a protein in the body that helps with many cell processes and acts as a target for cancer treatment in the form of PARP inhibitor drugs, such as niraparib. The Optune device, a device that uses low intensity, wave like electrical fields, called TTFields, may make cancer more sensitive to these types of drugs. [18F]FTT is a specialized radioactive imaging drug used to image areas where doctors think active tumors reside that might have PARP-1 activity after TTFields therapy. The purpose of this study is to test whether [18F]FTT can image PARP-1 activity in glioblastoma after TTFields therapy and whether radiotracer uptake correlates with response to treatment with the PARP inhibitor niraparib.
Additional locations may be listed on ClinicalTrials.gov for NCT04221061.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Evaluate uptake of fluorine F 18 fluorthanatrace ([18F]FTT) in recurrent glioblastoma after initiation of TTFields therapy.
SECONDARY AND EXPLORATORY OBJECTIVES:
I. To correlate [18F]FTT uptake measures with homologous recombination deficiency (HRD) status or other markers of “BRCAness”.
II. To determine pre-/post-treatment changes in [18F]FTT uptake after initiation of TTFields therapy.
III. To determine pre-/post-treatment changes in [18F]FTT uptake after initiation of PARP inhibitor.
IV. To correlate PARP expression by pathology testing with uptake of [18F]FTT in surgical subjects.
EXPLORATORY OBJECTIVE:
I. To determine whether pre-/post-treatment changes in [18F]FTT uptake predict clinical response as measured by disease control rate.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Beginning 3-7 days after initiation of TTFields therapy, patients who do not have a clinical indication for surgical resection receive [18F]FTT intravenously (IV) and undergo a PET/CT scan over 60 minutes. Patients may also receive [18F]FTT IV and undergo a PET/CT scan over 60 minutes at baseline prior to initiation of TTFields therapy, and at 1-21 days after initiation of niraparib.
COHORT B: Beginning 3-7 days after initiation of TTFields therapy, patients who have a clinical indication for surgical resection receive [18F]FTT IV and undergo a PET/CT scan over 60 minutes. Patients may also receive [18F]FTT IV and undergo a PET/CT scan over 60 minutes at baseline prior to initiation of TTFields therapy.
After completion of study, patients are followed up for 24 hours and then periodically thereafter.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorAustin Ryan Pantel
