WBSI Guided Personalized Delivery of TTFields

NCT05086497 | Recruiting DMC FDA Device

• 3 other identifiers: 093218487151R01CA262584-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Using whole brain spectroscopy imaging, diffusion and perfusion MR imaging, a combined multiparametric approach will be utilized to compare treatment response from patients enrolled in two study arms.

  2 month intervals

Secondary Outcomes (1)

• Overall Survival

  through study completion and clinical follow ups for up to 5 years

Study Arms (2)

Conventional Array Mapping Layout

NO INTERVENTION

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

Advanced MR Imaging Array Mapping Layout

EXPERIMENTAL

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

Diagnostic Test: Whole Brain Spectroscopy Imaging Array Mapping Layout

Interventions

Whole Brain Spectroscopy Imaging Array Mapping Layout DIAGNOSTIC_TEST

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.

Advanced MR Imaging Array Mapping Layout

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• NovoCure Ltd.: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Penn Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Suyash Mohan, MD, PDCC

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sanjeev Chawla, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Demetrius Lee

CONTACT

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

Neuroradiology Research Core

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 21, 2021
• Study Start: January 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)