What side effects are associated with this type of intervention?

Common treatments for glioblastoma include TTFields (Optune device), PARP inhibitors (niraparib), chemotherapy (temozolomide), and radiotherapy. TTFields can cause skin irritation and discomfort at the application site. PARP inhibitors may lead to fatigue, nausea, anemia, and thrombocytopenia. Chemotherapy with temozolomide often results in side effects such as nausea, vomiting, fatigue, and myelosuppression. Radiotherapy can cause hair loss, skin changes, fatigue, and cognitive effects. The use of 18F-Fluorthanatrace (18F-FTT) in PET/CT imaging is generally well-tolerated, but potential side effects include radiation exposure risks and allergic reactions to the tracer.

What prior FDA approvals exist?

The FDA has approved various treatments for glioblastoma, including the use of radioactive imaging agents in PET/CT scans to detect recurrent brain cancer. One such agent is 18F-Fluorthanatrace (18F-FTT), which is currently being studied for its efficacy in imaging glioblastoma. Other similar agents include 18F-fluciclovine, used in prostate cancer imaging, and fluoroestradiol F-18, used for detecting estrogen receptor-positive lesions in breast cancer. These agents help in the precise localization and assessment of cancer recurrence, aiding in the management and treatment planning for patients.

What other types of research exist?

Promising alternatives to 18F-Fluorthanatrace (18F-FTT) for glioblastoma imaging include 18F-FDOPA and 18F-FDG. 18F-FDOPA PET has shown viability for imaging and treatment planning of gliomas, potentially offering better efficacy compared to MRI and 18F-FDG PET. Additionally, 18F-FDG PET is commonly used for assessing brain tumors and has been compared favorably in studies for evaluating astrocytic tumors.

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PARP Inhibitor

18F-FluorThanatrace Imaging for Glioblastoma

Q: What is the mechanism of action of this treatment?

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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).

0 / 2Eligibility criteria met

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.