NCT05086497 WBSI Guided Personalized Delivery of TTFields
| NCT ID | NCT05086497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | GBM |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2023-01-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 155 participants in total. It began in 2023-01-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with "standard array mapping" (based on regular contrast enhanced MRI) or an "alternative (more precise) array mapping" based on sophisticated state of the art MRI techniques including "whole brain spectroscopy". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.
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.
Contact & Investigator
Suyash Mohan, MD, PDCC
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT05086497 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying GBM. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05086497 currently recruiting?
Yes, NCT05086497 is actively recruiting participants. Contact the research team at Demetrius.Lee@Pennmedicine.upenn.edu for enrollment information.
Where is the NCT05086497 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT05086497 clinical trial?
NCT05086497 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Suyash Mohan, MD, PDCC at University of Pennsylvania. The trial plans to enroll 155 participants.