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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Device: Standard Magnetic Resonance Imaging (MRI); Device: Advanced MRI.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Cathy Marszalkowski; Phone Number: 414-955-1183; Email: cmars@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53202
      • Recruiting
      • Froedtert Hospital & Medical College of Wisconsin
      • Contact: Jennifer Connelly, MD; Phone Number: 414-805-5200; Email: JConnelly@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with newly diagnosed or recurrent glioblastoma who have self-selected Optune therapy (group 1) or declined Optune therapy (group 2).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eligible Subjects; All enrolled subjects undergoing Optune therapy.	Device: Standard Magnetic Resonance Imaging (MRI); Standard MRI.; Device: Advanced MRI.; Perfusion and diffusion MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival.	The number of subjects alive at six months.	Six months.
Overall survival.	The number of subjects alive at one year.	One year.

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Jennifer Connelly, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Optune Therapy; NovoCure-TTF-200A
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: PRO00000087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No