RECRUITING

WBSI Guided Personalized Delivery of TTFields

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Conditions

GBMGlioma Glioblastoma MultiformeTumor, Brain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields

Quick Facts

Study Start:2023-01-15
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05086497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult population ≥ 22 years
  2. * Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
  3. * 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
  4. * 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and/or isocitrate dehydrogenase (IDH) mutant or IDH wild-type)
  5. * Possessing adequate hematological, hepatic and renal functions
  6. * Willingness to receive TTFields
  1. * Presence of infra-tentorial GBM
  2. * Pregnancy
  3. * Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
  4. * 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.
  5. * Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
  6. * Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.

Contacts and Locations

Study Contact

Demetrius Lee
CONTACT
267-408-0977
Demetrius.Lee@Pennmedicine.upenn.edu
Neuroradiology Research Core
CONTACT
215-662-7216
NeuroradiologyResearchCore@uphs.upenn.edu

Principal Investigator

Suyash Mohan, MD, PDCC
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Sanjeev Chawla, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Penn Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Suyash Mohan, MD, PDCC, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Sanjeev Chawla, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-15
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-01-15
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • GBM
  • Glioma Glioblastoma Multiforme
  • Tumor, Brain