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Electrical Therapy
TTFields for Brain Cancer
N/A
Recruiting
Led By Sanjeev Chawla, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult population ≥ 22 years
Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
Must not have
Presence of infra-tentorial GBM
Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and clinical follow ups for up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trialis testing a novel electrical therapy to treat brain tumors, using MRI to find where to direct the dose, to maximize effectiveness and improve survival & quality of life.
Who is the study for?
This trial is for adults over 22 with a confirmed diagnosis of Glioblastoma (GBM) who've had surgery and radiation therapy. They must have good blood, liver, and kidney function and be willing to receive TTFields treatment. It's not for those with GBM below the cerebellum, pregnant women, people with certain medical devices or skull defects, or sensitivity to conductive hydrogels.
What is being tested?
The study tests if an advanced MRI technique called 'whole brain spectroscopy' can better guide the placement of TTFields therapy compared to standard mapping. This could potentially improve survival rates and quality of life by more effectively targeting tumor cells in GBM patients.
What are the potential side effects?
While specific side effects are not listed for this trial, TTFields therapy may cause skin irritation under the device electrodes, headaches, malaise or muscle twitching. The precise side effects will depend on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Select...
My diagnosis of brain cancer is confirmed by lab tests.
Select...
I am willing to undergo TTFields therapy.
Select...
My cancer has specific genetic features (MGMT or IDH).
Select...
I've had surgery to remove as much of the tumor as safely possible, followed by a specific course of radiation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My brain tumor is located below the tentorium.
Select...
I have bleeding in the area of my tumor that could affect imaging tests.
Select...
I have health issues that would prevent me from taking TMZ treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and clinical follow ups for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and clinical follow ups for up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Progression
Secondary study objectives
Overall Survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Advanced MR Imaging Array Mapping LayoutExperimental Treatment1 Intervention
Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.
Group II: Conventional Array Mapping LayoutActive Control1 Intervention
Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,200 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
463,673 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
63 Previous Clinical Trials
5,920 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,425 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,078 Total Patients Enrolled
Sanjeev Chawla, PhDPrincipal InvestigatorUniversity of Pennsylvania
Suyash Mohan, MD, PDCCPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain tumor is located below the tentorium.I have bleeding in the area of my tumor that could affect imaging tests.I have health issues that would prevent me from taking TMZ treatment.I am 22 years old or older.My diagnosis of brain cancer is confirmed by lab tests.My blood, liver, and kidney functions are all within normal ranges.I am willing to undergo TTFields therapy.My cancer has specific genetic features (MGMT or IDH).I've had surgery to remove as much of the tumor as safely possible, followed by a specific course of radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Array Mapping Layout
- Group 2: Advanced MR Imaging Array Mapping Layout
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.