UPCC 09321 Whole-Brain Spectroscopy Guided Personalized Mapping Of Transducer Arrays For Glioblastoma Patients Receiving Tumor Treating Fields
Investigating Personalized Mapping for Glioblastoma Treatment
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: GBM, Glioma Glioblastoma Multiforme, Tumor, Brain
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Age: 22 years or above
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Gender: All
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.
This study investigates the effectiveness of personalized mapping techniques for patients with Glioblastoma, a type of brain cancer. The purpose of this study is to compare two different mapping methods used in tumor treating fields (TTFields) therapy, which is a type of electrical therapy that has shown to improve survival rates in patients. Participants will receive either the standard array mapping based on regular MRI scans or an alternative, more precise mapping using advanced MRI techniques, including whole-brain spectroscopy. This advanced technique provides more detailed information about the tumor's spread by identifying specific cancer cell metabolites.
Participants in the study will undergo procedures involving the use of Optune, a device that delivers TTFields. The study will compare the effectiveness of standard mapping versus alternative mapping in delivering TTFields. This involves the use of sophisticated MRI techniques to map the tumor more precisely and potentially improve the delivery of the treatment, aiming to reduce tumor recurrence and enhance the overall survival and quality of life for patients.
- Who can participate: Adults aged 22 years and older with confirmed Glioblastoma who have completed surgical resection and radiation therapy, have adequate organ function, and are willing to receive TTFields are eligible.
- Study details: Participants will use the Optune device to receive TTFields therapy. The study will compare standard mapping with advanced MRI-based mapping to assess treatment effectiveness.
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