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MRI Predictors of Response to Tumor Treating Fields

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ClinicalTrials.gov Identifier: NCT03642080
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Theodore Yanagihara, New York Presbyterian Brooklyn Methodist Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    Clinical or radiographic disease progression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642080


Contacts
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Contact: Adel Guirguis, MD, MS 718-780-3677 adg9003@nyp.org
Contact: Hani Ashamalla, MD 718-780-3677 hashamalla@gmail.com

Locations
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United States, New York
New York Presbyterian - Brooklyn Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Adel Guirguis, MD, MS    718-780-3677    adg9003@nyp.org   
Contact: Hani Ashamalla, MD    718-780-3677    hashamalla@gmail.com   
Principal Investigator: Theodore Yanagihara', MD, PhD         
Sponsors and Collaborators
New York Presbyterian Brooklyn Methodist Hospital
Investigators
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Study Director: Adel Guirguis, MD, MS New York Presbyterian Hospital - Brooklyn Methodist Hospital
More Information
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Additional Information:

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Responsible Party: Theodore Yanagihara, Assistant Professor of Clinical Radiation Oncology, New York Presbyterian Brooklyn Methodist Hospital
ClinicalTrials.gov Identifier: NCT03642080    
Other Study ID Numbers: 1137708
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue