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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Abramson Cancer Center
RECRUITING
Philadelphia
Penn Medicine, University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Demetrius Lee
Demetrius.Lee@Pennmedicine.upenn.edu
267-408-0977
Backup
Neuroradiology Research Core
NeuroradiologyResearchCore@uphs.upenn.edu
215-662-7216
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 155
Treatments
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.
Sponsors
Collaborators: NovoCure Ltd., National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov