Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||22 Years and Over|
- - 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.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Abramson Cancer Center of the University of Pennsylvania|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Suyash Mohan, MD, PDCCSanjeev Chawla, PhD|
|Principal Investigator Affiliation||University of PennsylvaniaUniversity of Pennsylvania|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Other, Industry, NIH|
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|GBM, Glioma Glioblastoma Multiforme, Tumor, Brain|
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.
Diagnostic Test: - 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.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.