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Companion treatment trial closed early with negative results. No imaging study participants completed the full study imaging planned due to logistical difficulties.
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical candidates | Other | In this arm, subjects that do not have a clinical indication for surgical resection of the recurrent tumor will start TTFields therapy 5-7 days prior to starting oral niraparib (a PARP inhibitor). |
|
| Surgical candidates | Other | In this arm, subjects who have a clinical indication for surgical resection of the recurrent tumor will receive TTFields therapy for 5-7 days prior to planned surgical resection, undergo resection, and then resume TTFields therapy and initiate niraparib post-operatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FluorThanatrace | Drug | 18F-FluorThanatrace is a novel radiopharmaceutical which measure PARP-1 expression using a Positron Emission Tomography (PET/CT) scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy. | Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness". | Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness". To determine pre-/post-treatment changes in [18F]FTT uptake after initiation of TTFields therapy. To determine pre-/post-treatment changes in [18F]FTT uptake after initiation of PARP inhibitor. To correlate PARP expression by pathology testing with uptake of [18F]FTT in surgical subjects. |
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Inclusion Criteria:
Exclusion Criteria:
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Austin R Pantel, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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|
| 3 years |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |