WBSI Guided Personalized Delivery of TTFields

GBM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086497
• Other study ID #: 09321
• Secondary ID: 8487151R01CA2625
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Demetrius Lee
• Phone: 267-408-0977
• Email: Demetrius.Lee[@]Pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• GBM
• Glioblastoma
• Glioma Glioblastoma Multiforme
• Tumor, Brain

Intervention

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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Penn Medicine, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH), NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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