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| ID | Type | Description | Link |
|---|---|---|---|
| 848715 | Other Identifier | IRB | |
| 1R01CA262584-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Brain Spectroscopy Imaging Array Mapping Layout | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 month intervals |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time until local recurrence and overall survival status will be calculated in months | through study completion and clinical follow ups for up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demetrius Lee | Contact | 267-408-0977 | Demetrius.Lee@Pennmedicine.upenn.edu | |
| Neuroradiology Research Core | Contact | 215-662-7216 | NeuroradiologyResearchCore@uphs.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suyash Mohan, MD, PDCC | University of Pennsylvania | Principal Investigator |
| Sanjeev Chawla, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Penn Medicine, University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |