Advanced MR Imaging Array Mapping Layout for Glioblastoma Multiforme

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma Multiforme+2 MoreWhole Brain Spectroscopy Imaging Array Mapping Layout - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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. 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.

Eligible Conditions
  • Brain Tumor
  • Glioblastoma Multiforme

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: through study completion and clinical follow ups for up to 5 years

2 month intervals
Time to Progression
Year 5
Overall Survival

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Conventional Array Mapping Layout
1 of 2
Advanced MR Imaging Array Mapping Layout
1 of 2

Active Control

Experimental Treatment

155 Total Participants · 2 Treatment Groups

Primary Treatment: Advanced MR Imaging Array Mapping Layout · No Placebo Group · N/A

Advanced MR Imaging Array Mapping Layout
DiagnosticTest
Experimental Group · 1 Intervention: Whole Brain Spectroscopy Imaging Array Mapping Layout · Intervention Types: DiagnosticTest
Conventional Array Mapping LayoutNoIntervention Group · 1 Intervention: Conventional Array Mapping Layout · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion and clinical follow ups for up to 5 years

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
350 Previous Clinical Trials
104,773 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
53 Previous Clinical Trials
4,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,316 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,123 Total Patients Enrolled
Suyash Mohan, MD, PDCCPrincipal InvestigatorUniversity of Pennsylvania
Sanjeev Chawla, PhDPrincipal InvestigatorUniversity of Pennsylvania

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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