WBSI Guided Personalized Delivery of TTFields

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

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.

Study Overview

• Status: Recruiting
• Conditions: GBM; Tumor, Brain; Glioma Glioblastoma Multiforme
• Intervention / Treatment: Diagnostic test: Whole Brain Spectroscopy Imaging Array Mapping Layout

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neuroradiology Research Core; Phone Number: 215-662-7216; Email: NeuroradiologyResearchCore@uphs.upenn.edu
• Study Contact Backup: Name: Demetrius Lee; Phone Number: 267-408-0977; Email: demetrius.lee@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center
      • Contact: Demetrius Lee; Phone Number: 267-408-0977; Email: demetrius.lee@pennmedicine.upenn.edu
      • Contact: Kristina Vineis; Email: kristina.vineis@pennmedicine.upenn.edu
      • Principal Investigator: Suyash Mohan, MD
      • Principal Investigator: Sanjeev Chawla, PhD
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine, University of Pennsylvania
      • Contact: Demetrius Lee; Phone Number: 267-408-0977; Email: demetrius.lee@pennmedicine.upenn.edu
      • Contact: Kristina Vineis; Email: kristina.vineis@pennmedicine.upenn.edu
      • Principal Investigator: Suyash Mohan, MD
      • Principal Investigator: Sanjeev Chawla, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); NovoCure Ltd.
• Investigators: Principal Investigator: Suyash Mohan, MD, PDCC, University of Pennsylvania; Principal Investigator: Sanjeev Chawla, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioblastoma; Brain Neoplasms
• Other Study ID Numbers: 09321; 848715 (Other Identifier: IRB); 1R01CA262584-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No