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

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 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.

Inclusion Criteria:

- Newly diagnosed glioblastoma (GBM), 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 (i.e. DBS, spinal cord stimulator, pacemaker,
defibrillator, vagus nerve stimulator, programmable shunt).

- Karnofsky Performance Status (KPS) < 60.