MRI Predictors of Response to Tumor Treating Fields
Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma
1 other identifier
observational
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 19, 2018
December 1, 2018
2.8 years
April 13, 2018
December 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
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.
Eligibility Criteria
Any patient with newly diagnosed or with recurrent glioblastoma who meet the eligibility criteria of the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adel Guirguis, MD, MS
New York Presbyterian Hospital - Brooklyn Methodist Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Radiation Oncology
Study Record Dates
First Submitted
April 13, 2018
First Posted
August 22, 2018
Study Start
December 1, 2018
Primary Completion
September 30, 2021
Study Completion
December 31, 2023
Last Updated
December 19, 2018
Record last verified: 2018-12