MRI Predictors of Response to Tumor Treating Fields

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642080
• Other study ID #: 1137708
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2018
• Source: New York Methodist Hospital
• Contact: Adel Guirguis, MD, MS
• Phone: 718-780-3677
• Email: adg9003[@]nyp.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Locations

Country	Name	City	State
United States	New York Presbyterian - Brooklyn Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.