NCT05086497Recruiting
WBSI Guided Personalized Delivery of TTFields
Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 155 (estimated)
- First submitted
- 22 Sept 2021
- Start date
- Jan 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT05086497
What you commit to
- Study type: Interventional
- Planned participants: 155
- From Jan 2023 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn Medicine, University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.