Recruiting

Optune

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05086497

Conditions

GBM

Glioma Glioblastoma Multiforme

Tumor, Brain

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Whole Brain Spectroscopy Imaging Array Mapping Layout

Study Details

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.

Conditions

GBM

Glioma Glioblastoma Multiforme

Tumor, Brain

Study ID

NCT05086497

Start date

Jan 15, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Conventional Array Mapping Layout

Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.

experimental: Advanced MR Imaging Array Mapping Layout

Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.

Interventions

Whole Brain Spectroscopy Imaging Array Mapping Layout

All study participants will receive whole brain spectroscopy imaging as a part of MRI study time points. Participants assigned to the advanced MR imaging array mapping layout study arm will receive tumor treating fields mapping from Optune that is created from the spectroscopy sequences or advanced MR imaging. Participants assigned to the conventional array mapping layout will still receive advanced imaging sequences or spectroscopy imaging at all time points.

Primary outcome measure

  • Time to Progression [ Time Frame: 2 month intervals ]

Central Contacts and Locations

Central contacts

Demetrius Lee

267-408-0977Demetrius.Lee@Pennmedicine.upenn.edu

Neuroradiology Research Core

215-662-7216NeuroradiologyResearchCore@uphs.upenn.edu

Locations

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Demetrius Lee

2674080977demetrius.lee@pennmedicine.upenn.edu

Kristina Vineis

kristina.vineis@pennmedicine.upenn.edu

Principal Investigator:

Suyash Mohan, MD

Penn Medicine, University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Demetrius Lee

2674080977demetrius.lee@pennmedicine.upenn.edu

Kristina Vineis

kristina.vineis@pennmedicine.upenn.edu

Principal Investigator:

Suyash Mohan, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-08-06.