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PARP Inhibitor

18F-FluorThanatrace Imaging for Glioblastoma

Phase < 1
Waitlist Available
Led By Austin R Pantel, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, IRB 832694.
Participants will be ≥ 22 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial involves using a device that sends low-intensity electrical fields, a drug that stops cancer cells from repairing themselves, and a special imaging drug to see brain cancer. It targets patients with recurrent brain cancer to test how well the imaging drug can detect cancer before or after new treatments or surgery. This trial uses a device that sends low-intensity electrical fields to the tumor area.

Who is the study for?
This trial is for adults over 22 with glioblastoma who are also part of a treatment study using TTFields and niraparib. They must understand the research nature of this study, agree to it in writing, and be able to undergo PET/CT scans without issues.
What is being tested?
The trial tests how well a new radioactive imaging drug called 18F-Fluorthanatrace (18F-FTT) works in detecting recurrent brain cancer when used with PET/CT scanning before or after treatment or surgery.
What are the potential side effects?
Potential side effects aren't specified here but may include reactions related to the injection of the radioactive substance, such as discomfort at the injection site, allergic reactions, or changes due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have glioblastoma and am enrolled in the IRB 832694 trial.
Select...
I am 22 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate uptake of [18F]FTT in recurrent glioblastoma after initiation of TTFields therapy.
Secondary study objectives
Correlate [18F]FTT uptake measures with Homologous recombination deficiency (HRD) status or other markers of "BRCAness".

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Surgical candidatesExperimental Treatment1 Intervention
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.
Group II: Non-surgical candidatesExperimental Treatment1 Intervention
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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible. Radiation therapy uses high-energy waves to kill cancer cells and shrink tumors. Chemotherapy, such as temozolomide, works by damaging the DNA of cancer cells, preventing them from dividing and growing. Additionally, treatments like Tumor Treating Fields (TTFields) use electrical fields to disrupt cancer cell division. Imaging agents like 18F-Fluorthanatrace (18F-FTT) in PET/CT scans are crucial as they help detect recurrent brain cancer, allowing for timely adjustments in treatment plans. This is vital for Glioblastoma patients due to the aggressive nature of the disease and the need for precise monitoring and intervention.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,066 Previous Clinical Trials
42,712,906 Total Patients Enrolled
7 Trials studying Glioblastoma
193 Patients Enrolled for Glioblastoma
Austin R Pantel, MDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04221061 — Phase < 1
Glioblastoma Research Study Groups: Non-surgical candidates, Surgical candidates
Glioblastoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT04221061 — Phase < 1
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221061 — Phase < 1
~1 spots leftby Oct 2025