WBSI Guided Personalized Delivery of TTFields

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05086497
Status
Recruiting
Apply to this trial

Conditions

  • GBM
  • Glioma Glioblastoma Multiforme
  • Tumor, Brain

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Time to Progression [ Time Frame: 2 month intervals ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Abramson Cancer CenterPhiladelphiaPennsylvania19104
Demetrius Lee
[email protected]
267-408-0977
Kristina Vineis
[email protected]
Suyash Mohan, MD (PRINCIPAL_INVESTIGATOR)
Sanjeev Chawla, PhD (PRINCIPAL_INVESTIGATOR)
Penn Medicine, University of PennsylvaniaPhiladelphiaPennsylvania19104
Demetrius Lee
[email protected]
267-408-0977
Kristina Vineis
[email protected]
Suyash Mohan, MD (PRINCIPAL_INVESTIGATOR)
Sanjeev Chawla, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Abramson Cancer Center· Philadelphia, PAPenn Medicine, University of Pennsylvania· Philadelphia, PA

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