Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
155 participants
INTERVENTIONAL
2023-01-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Conventional Array Mapping Layout
Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
ALL
No
Sponsors
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NovoCure Ltd.
INDUSTRY
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Suyash Mohan, MD, PDCC
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Sanjeev Chawla, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Penn Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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848715
Identifier Type: OTHER
Identifier Source: secondary_id
09321
Identifier Type: -
Identifier Source: org_study_id
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