WBSI Guided Personalized Delivery of TTFields

Last updated: February 7, 2025
Sponsor: Abramson Cancer Center at Penn Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gliomas

Astrocytoma

Treatment

Whole Brain Spectroscopy Imaging Array Mapping Layout

Clinical Study ID

NCT05086497
09321
848715
1R01CA262584-01
  • Ages > 22
  • All Genders

Study 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

Inclusion Criteria:

  • Adult population ≥ 22 years

  • Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOWcriteria

  • Have undergone maximal safe surgical resection followed by either standard fullcourse 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/orisocitrate dehydrogenase (IDH) mutant or IDH wild-type)

  • Possessing adequate hematological, hepatic and renal functions

  • Willingness to receive TTFields

Exclusion

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 noreplacement) or bullet fragments. Examples of active electronic devices include deepbrain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers,defibrillators and programmable shunts. , other implanted electronic devices in thebrain.

  • 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 potentiallydegrade the image quality.

Study Design

Total Participants: 155
Treatment Group(s): 1
Primary Treatment: Whole Brain Spectroscopy Imaging Array Mapping Layout
Phase:
Study Start date:
January 15, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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