RecruitingNot ApplicableNCT05086497

WBSI Guided Personalized Delivery of TTFields

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

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

155 participants

Start Date

Jan 15, 2023

Study Type

INTERVENTIONAL

Conditions

GBM Tumor, Brain Glioma Glioblastoma Multiforme

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized version of a wearable brain cancer treatment called TTFields (Tumor Treating Fields). TTFields uses mild electric fields to slow the growth of brain tumor cells. This trial uses brain imaging to customize exactly where the device focuses those fields for each patient with glioblastoma. **You may be eligible if...** - You have been diagnosed with glioblastoma (a type of aggressive brain cancer) - You have already completed surgery and radiation (either a standard 6-week course or a shorter 3-week course) - You are 22 years of age or older - Your blood, liver, and kidney function are adequate - You are willing to wear the TTFields device **You may NOT be eligible if...** - Your tumor is located in the lower part of the brain (infratentorial region) - You are pregnant - You have an implanted electronic device such as a pacemaker, deep brain stimulator, or programmable shunt - You have a skull defect with no replacement (e.g., missing bone) - You are allergic to the type of gel used on ECG stickers - You have significant bleeding around the tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.

Locations(2)

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Penn Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05086497

Related Trials

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

NCT073265664 locations

Sonodynamic Therapy in Patients With Recurrent GBM

NCT060397091 location

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

NCT0590216948 locations

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

NCT0638873395 locations

Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma

NCT072256218 locations