Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
ID05086497

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

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-03-11

155

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Abramson Cancer Center at Penn Medicine

Lead Sponsor

N

NovoCure Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying Glioblastoma (GBM) patients who will begin treatment with Optune, a therapy that uses tumor treating fields (TTFields) or electrical therapy. The study aims to compare the effectiveness of standard array mapping based on regular MRI with an advanced mapping method using whole brain spectroscopy, a detailed MRI technique that reveals tumor spread beyond visible areas. This research seeks to determine if the advanced mapping improves treatment outcomes, reduces local recurrence, and enhances survival and quality of life. Participants will be randomly assigned to one of two groups: one receiving Optune mapping guided by standard MRI sequences, and the other receiving mapping based on advanced MRI including whole brain spectroscopy. All participants will undergo whole brain spectroscopy imaging at MRI study time points, but only the experimental group will have their array mapping created using these advanced imaging sequences. This design allows comparison of the two mapping methods while all receive the TTFields therapy. During the study, participants will be monitored about every two months to track time to progression, which is the main measure of how the disease advances. Researchers will also observe overall survival through clinical follow-ups for up to five years. Safety evaluations, imaging studies, and clinical assessments will be conducted regularly. This trial is led by the Abramson Cancer Center at Penn Medicine and involves triple blinding to reduce bias. Participant involvement includes undergoing imaging, receiving TTFields treatment, and routine clinical evaluations throughout the study period.

CONDITIONS

Brief Title

WBSI Guided Personalized Delivery of TTFields

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 22 years or older
  • Histologically confirmed diagnosis of Glioblastoma or molecular Glioblastoma according to c-IMPACT NOW criteria
  • Have undergone maximal safe surgical resection followed by standard full course radiation of 6000 cGy in 6 weeks or hypofractionated course of 4000 cGy in 3 weeks
  • Harbor any genotype profiles including MGMT promoter methylation or unmethylation, and/or IDH mutant or IDH wild-type
  • Possess adequate hematological, hepatic, and renal functions
  • Willingness to receive tumor treating fields (TTFields) therapy
Not Eligible

You will not qualify if you...

  • Presence of infra-tentorial Glioblastoma
  • Pregnancy
  • Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
  • Active implanted medical devices such as deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, programmable shunts, or other implanted electronic devices in the brain
  • Skull defect such as missing bone with no replacement
  • Presence of bullet fragments
  • Sensitivity to conductive hydrogels used on ECG stickers or transcutaneous electrical nerve stimulation electrodes
  • Significant hemorrhage in and around the tumor bed that may degrade image quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At trial enrollment and repeated at specified MRI study time points

Participants undergo whole brain spectroscopy imaging and advanced MR imaging sequences to guide personalized tumor treating fields array mapping.

Multiple imaging visits as scheduled during the study

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for time to progression and overall survival after imaging assessments, with follow-up visits extending up to 5 years.

Follow-up visits approximately every 2 months initially, then as clinically indicated

Trial Site Locations

Total: 2 locations

1

Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

2

Penn Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

D

Demetrius Lee

N

Neuroradiology Research Core

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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