Personalized delivery of tumor treating fields for glioblastoma patients

Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields

This study is testing if a new way of mapping brain tumors can help glioblastoma patients using Optune treatment live longer and feel better compared to the standard method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Philadelphia, Pennsylvania and 1 other locations)
• Trial ID: NCT05086497 on ClinicalTrials.gov

What this trial studies

This research focuses on glioblastoma patients starting treatment with Optune, which uses tumor treating fields (TTFields) to improve survival rates. Participants will be assigned to receive either standard array mapping based on regular MRI or a more precise array mapping using advanced whole brain spectroscopy techniques. This innovative approach aims to enhance treatment outcomes by accurately identifying the extent of tumor spread within the brain. The study seeks to determine if the alternative mapping method leads to better results compared to the standard approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with a confirmed diagnosis of glioblastoma who have undergone surgical resection and are willing to receive TTFields.

Not a fit: Patients with infra-tentorial GBM, significant co-morbidities, or active implanted medical devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes and survival rates for glioblastoma patients.

How similar studies have performed: Other studies utilizing tumor treating fields have shown promising results, indicating potential for success with this novel mapping approach.

Eligibility criteria

Inclusion Criteria:

* Adult population ≥ 22 years
* Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
* Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course of 4000 cGy in 3 weeks
* 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and/or isocitrate dehydrogenase (IDH) mutant or IDH wild-type)
* Possessing adequate hematological, hepatic and renal functions
* Willingness to receive TTFields

Exclusion Criteria:

* Presence of infra-tentorial GBM
* Pregnancy
* Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
* Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers, defibrillators and programmable shunts. , other implanted electronic devices in the brain.
* Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
* Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.

Where this trial is running

Philadelphia, Pennsylvania and 1 other locations

• Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
• Penn Medicine, University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Suyash Mohan, MD, PDCC — University of Pennsylvania
• Study coordinator: Demetrius Lee

Conditions GBM; Glioma Glioblastoma Multiforme; Tumor, Brain