GBMNCT05086497
WBSI Guided Personalized Delivery of TTFields
A study testing Whole Brain Spectroscopy Imaging Array Mapping Layout in people with GBM and Glioma Glioblastoma Multiforme, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- GBM, Glioma Glioblastoma Multiforme, Tumor, Brain
- What is being tested?
- Whole Brain Spectroscopy Imaging Array Mapping Layout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2023to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Demetrius Lee, 2674080977, demetrius.lee@pennmedicine.upenn.edu
Kristina Vineis, kristina.vineis@pennmedicine.upenn.edu
- Recruiting
Penn Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Demetrius Lee, 2674080977, demetrius.lee@pennmedicine.upenn.edu
Kristina Vineis, kristina.vineis@pennmedicine.upenn.edu
About this study
Official title: Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields
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.
- Conditions
- GBM, Glioma Glioblastoma Multiforme, Tumor, Brain
- Being tested
- Whole Brain Spectroscopy Imaging Array Mapping Layout
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Brain Spectroscopy Imaging Array Mapping LayoutDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Array Mapping Layout | No intervention | Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences. |
| Advanced MR Imaging Array Mapping Layout | Experimental | Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment. Receives: Diagnostic Test: Whole Brain Spectroscopy Imaging Array Mapping Layout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month intervals
Secondary outcomes (1)
Overall Survival
Time until local recurrence and overall survival status will be calculated in months
Measured: through study completion and clinical follow ups for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start15 Jan 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd., National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suyash Mohan, MD, PDCC, Principal investigator, University of PennsylvaniaSanjeev Chawla, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086497
- Sponsor's protocol ID
- 09321
- Other IDs
- 848715, 1R01CA262584-01
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No