WBSI Guided Personalized Delivery of TTFields

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05086497
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abramson Cancer Center at Penn Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Suyash Mohan, MD, PDCCSanjeev Chawla, PhD
Principal Investigator Affiliation	University of PennsylvaniaUniversity of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	GBM, Glioma Glioblastoma Multiforme, Tumor, Brain

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Abramson Cancer Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Site Contact

Demetrius Lee

[email protected]

267-408-0977

Philadelphia, Pennsylvania

Status