WBSI Guided Personalized Delivery of TTFields

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Oct 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver a treatment called Optune for patients with Glioblastoma (GBM), a type of brain cancer. Optune uses tumor treating fields (TTFields), which are electrical signals designed to target cancer cells and improve survival rates. In this study, participants will receive either the standard method of applying the treatment, based on regular MRI scans, or a more advanced method that uses specialized MRI techniques to get a clearer picture of the tumor. The goal is to see if this more precise mapping can help deliver the TTFields more effectively, potentially leading to better outcomes in fighting the tumor and improving the patients’ quality of life.

To be eligible for this trial, participants must be adults aged 22 or older with a confirmed diagnosis of GBM, and they should have already had surgery and radiation treatment. They must also be healthy enough to receive the treatment and willing to participate. Throughout the study, participants will receive close monitoring and care to ensure their safety and to gather valuable information about how well the treatment works. This trial is currently recruiting, and it aims to find innovative ways to enhance treatment for those facing this challenging condition.

Gender

ALL

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.