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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297125
• Other study ID #: PRO00000087
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Medical College of Wisconsin
• Contact: Cathy Marszalkowski
• Phone: 414-955-1183
• Email: cmars[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Device:
• Standard Magnetic Resonance Imaging (MRI)
Standard MRI.
• Advanced MRI.
Perfusion and diffusion MRI.

Locations

Country	Name	City	State
United States	Froedtert Hospital & Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival.	The number of subjects alive at six months.	Six months.
Primary	Overall survival.	The number of subjects alive at one year.	One year.