WBSI Guided Personalized Delivery of TTFields

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05086497

Enrollment

155

Registered

2021-10-21

Start date

2023-01-15

Completion date

2027-06-30

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GBM, Glioma Glioblastoma Multiforme, Tumor, Brain

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.

Interventions

DIAGNOSTIC_TESTWhole 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Progression	2 month intervals	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.

Secondary

Measure	Time frame	Description
Overall Survival	through study completion and clinical follow ups for up to 5 years	Time until local recurrence and overall survival status will be calculated in months

Countries

United States

Contacts

CONTACTDemetrius Lee

Demetrius.Lee@Pennmedicine.upenn.edu267-408-0977

CONTACTNeuroradiology Research Core

NeuroradiologyResearchCore@uphs.upenn.edu215-662-7216

PRINCIPAL_INVESTIGATORSuyash Mohan, MD, PDCC

University of Pennsylvania

PRINCIPAL_INVESTIGATORSanjeev Chawla, PhD