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18F-FluorThanatrace (PET/CT) in Glioblastoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Participants will be ≥ 22 years of age. 2. Participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, IRB 832694. 3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04221061
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Pennsylvania
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Austin R Pantel, MD
Principal Investigator Affiliation	University of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Other: Non-surgical candidates

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).

Other: Surgical candidates

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.

Interventions

Drug: - 18F-FluorThanatrace

18F-FluorThanatrace is a novel radiopharmaceutical which measure PARP-1 expression using a Positron Emission Tomography (PET/CT) scan.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Erin Schubert

erinschu@pennmedicine.upenn.edu

215-573-6569

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