Clinical trial NCT05086497: WBSI Guided Personalized Delivery of TTFields
Official title: Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GBM
Glioma Glioblastoma Multiforme
Tumor, Brain
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2021-10-21
Enrollment: 155
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Time to Progression
timeFrame: 2 month intervals
Secondary outcomes:
measure: Overall Survival
timeFrame: through study completion and clinical follow ups for up to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Suyash Mohan, MD, PDCC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Sanjeev Chawla, PhD
role: PRINCIPAL_INVESTIGATOR
References: