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WBSI Guided Personalized Delivery of TTFields

Primary Purpose

GBM, Glioma Glioblastoma Multiforme, Tumor, Brain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whole Brain Spectroscopy Imaging Array Mapping Layout

About this trial

This is an interventional diagnostic trial for GBM

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Abramson Cancer CenterRecruiting
Penn Medicine, University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Array Mapping Layout

Advanced MR Imaging Array Mapping Layout

Arm Description

Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.

Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Time until local recurrence and overall survival status will be calculated in months

Full Information

NCT ID

NCT05086497

First Posted

September 22, 2021

Last Updated

January 19, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

NovoCure Ltd., National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05086497

Brief Title

WBSI Guided Personalized Delivery of TTFields

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2023 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

NovoCure Ltd., National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GBM, Glioma Glioblastoma Multiforme, Tumor, Brain

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional Array Mapping Layout

Arm Type

No Intervention

Arm Description

Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.

Arm Title

Advanced MR Imaging Array Mapping Layout

Arm Type

Experimental

Arm Description

Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.

Intervention Type

Diagnostic Test

Intervention Name(s)

Whole Brain Spectroscopy Imaging Array Mapping Layout

Intervention Description

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 Measure Information:

Title

Time to Progression

Description

Time Frame

2 month intervals

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Time until local recurrence and overall survival status will be calculated in months

Time Frame

through study completion and clinical follow ups for up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Demetrius Lee

Phone

267-408-0977

Demetrius.Lee@Pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Neuroradiology Research Core

Phone

215-662-7216

NeuroradiologyResearchCore@uphs.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suyash Mohan, MD, PDCC

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sanjeev Chawla, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Demetrius Lee

Phone

267-408-0977

demetrius.lee@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Kristina Vineis

kristina.vineis@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Suyash Mohan, MD

First Name & Middle Initial & Last Name & Degree

Sanjeev Chawla, PhD

Facility Name

Penn Medicine, University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Demetrius Lee

Phone

267-408-0977

demetrius.lee@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Kristina Vineis

kristina.vineis@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Suyash Mohan, MD

First Name & Middle Initial & Last Name & Degree

Sanjeev Chawla, PhD

12. IPD Sharing Statement

Plan to Share IPD

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WBSI Guided Personalized Delivery of TTFields

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