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WBSI Guided Personalized Delivery of TTFields

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ClinicalTrials.gov Identifier: NCT05086497
Recruitment Status : Not yet recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Collaborators:
NovoCure Ltd.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
GBM Glioma Glioblastoma Multiforme Tumor, Brain Diagnostic Test: Whole Brain Spectroscopy Imaging Array Mapping Layout Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 2 month intervals ]
    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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: through study completion and clinical follow ups for up to 5 years ]
    Time until local recurrence and overall survival status will be calculated in months



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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. 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086497


Contacts
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Contact: Lauren Karpf, BS, RT (R) 215-662-7274 lauren.karpf@pennmedicine.upenn.edu
Contact: Neuroradiology Research Core 215-662-7216 NeuroradiologyResearchCore@uphs.upenn.edu

Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
NovoCure Ltd.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Suyash Mohan, MD, PDCC University of Pennsylvania
Principal Investigator: Sanjeev Chawla, PhD University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05086497    
Other Study ID Numbers: 09321
848715 ( Other Identifier: IRB )
1R01CA262584-01 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases