Recruiting

Tumor Treating Fields

Sponsor:

New York Presbyterian Brooklyn Methodist Hospital

Code:

NCT03642080

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Glioblastoma Multiforme

Study ID

NCT03642080

Start date

Dec 1, 2018

Status verified date

Dec, 2018

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Progression of disease [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Adel Guirguis, MD, MS

718-780-3677adg9003@nyp.org

Hani Ashamalla, MD

718-780-3677hashamalla@gmail.com

Locations

New York Presbyterian - Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Adel Guirguis, MD, MS

718-780-3677adg9003@nyp.org

Hani Ashamalla, MD

718-780-3677hashamalla@gmail.com

Principal Investigator:

Theodore Yanagihara', MD, PhD

More Information

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Last update posted

Dec 19, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Presbyterian Brooklyn Methodist Hospital on 2018-12-19.