MRI Predictors of Response to Tumor Treating Fields

Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma

Patients with glioblastoma, an aggressive brain tumor, are recommended to undergo treatment with tumor treating fields using the Optune device as part of standard of care therapy. While undergoing treatment, patients are monitored regularly with brain MRI scans to look for tumor progression, but there are currently no means to predict which, or when, patients will progress. The purpose of the current study is to prospectively analyze these MRI scans to look for subtle imaging markers that can predict for future brain tumor progression while undergoing tumor treating field therapy.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme

Detailed Description

The proposed trial involves the prospective collection of imaging data at standard clinical time points before and during treatment with TTFields. All patients who are offered treatment with TTFields will also be offered enrollment in this non-randomized, observational study. Imaging data will include the standard battery of MRI sequences, which includes DWI and ADC reconstruction. These data will be collected at standard time points and the proposed study will not rely on any additional imaging or tests outside of the clinical standard of care.

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

• Study Contact: Name: Adel Guirguis, MD, MS; Phone Number: 718-780-3677; Email: adg9003@nyp.org
• Study Contact Backup: Name: Hani Ashamalla, MD; Phone Number: 718-780-3677; Email: hashamalla@gmail.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • Recruiting
      • New York Presbyterian - Brooklyn Methodist Hospital
      • Contact: Adel Guirguis, MD, MS; Phone Number: 718-780-3677; Email: adg9003@nyp.org
      • Contact: Hani Ashamalla, MD; Phone Number: 718-780-3677; Email: hashamalla@gmail.com
      • Principal Investigator: Theodore Yanagihara', MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient with newly diagnosed or with recurrent glioblastoma who meet the eligibility criteria of the study.

Description

Inclusion Criteria:

• Patients age 18 or older with newly diagnosed WHO grade IV glioblastoma or patients with recurrent glioblastoma not previously treated with TTFields.
• Patients may have undergone surgical resection or biopsy.
• Residual tumor, absence of treatment with temozolomide or radiation therapy will not be an exclusion criteria for the study.

Exclusion Criteria:

• Patients previously treated with TTFields will not be included in the study.
• Patients will also be excluded if they are undergoing active treatment with systemic agents, including bevacizumab, during treatment with TTFields.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Glioblastoma; Patients with a diagnosis of newly diagnosed or recurrent glioblastoma who have been treated with radiation and temozolomide and are being offered tumor treated fields.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of disease	Clinical or radiographic disease progression	Until discontinuation of tumor treating fields, progression or death. This will be evaluated by imaging and clinical exam from the time of trial enrollment until up to 36 months at approximately three-month intervals.

Collaborators and Investigators

• Sponsor: New York Presbyterian Brooklyn Methodist Hospital
• Investigators: Study Director: Adel Guirguis, MD, MS, New York Presbyterian Hospital - Brooklyn Methodist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• 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: 1137708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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