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Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI

Study Purpose

The purpose of this prospective, nonrandomized controlled phase IV study is to compare standard and advanced MRI for their ability to predict response to Optune therapy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Newly diagnosed glioblastoma (GBM), World Health Organization (WHO) grade IV.

Exclusion Criteria:

- Optune compliance < 75%; they would be excluded from the final analyses.

- History of craniectomy or significant skull defect (contraindication to Optune).

- Active implantable medical device (e.g., deep brain stimulator (DBS), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).

- Karnofsky Performance Status (KPS) < 60.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03297125
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical College of Wisconsin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jennifer Connelly, MD
Principal Investigator Affiliation	Medical College of Wisconsin
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

Protocol Summary: Optune therapy is a newly approved treatment for patients with glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM, in comparison to standard therapies, but better quality of life. More recently, in an interim analysis of 315 patients with GBM, adding Tumor Treating Fields (TTFields) to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival. It also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and lung. However, in order to optimize the treatment regimen, and potentially predict which patients are most likely to respond, reliable ways of evaluation are necessary. Advanced perfusion and diffusion MRI methods have shown utility with other treatments such as bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune therapy. The team therefore proposes to determine the utility of these methods to predict response to Optune therapy. A successful result will have wide-ranging implications not only for the optimization of Optune treatment of brain cancer but also other cancers shown to benefit from this novel therapy. Objective: To compare standard and advanced MRI for their ability to predict response to Optune therapy. The team's approach will be to obtain both standard and advanced MRI in patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune therapy. The ability of standard and advanced MRI to predict response will be assessed. The hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response to and elucidate mechanisms of action for Optune treatment.

Arms & Interventions

Arms

: Eligible Subjects

All enrolled subjects undergoing Optune therapy.

Interventions

Device: - Standard Magnetic Resonance Imaging (MRI)

Standard MRI.

Device: - Advanced MRI.

Perfusion and diffusion MRI.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53202

Site Contact

Jennifer Connelly, MD

JConnelly@mcw.edu

414-805-5200

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