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Trial record 4 of 17 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | glioma | United States | First posted from 04/01/2019 to 07/31/2019
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Resting-State Functional MRI in Glioma Patients Before and After Surgery

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ClinicalTrials.gov Identifier: NCT03964909
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

Condition or disease Intervention/treatment Phase
Brain Mass Glioma Procedure: Functional Magnetic Resonance Imaging Procedure: Magnetic Resonance Imaging Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.

SECONDARY OBJECTIVES:

I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.

OUTLINE:

Patients undergo standard of care functional (f)MRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

After completion of study, patients are followed up at 4-6 weeks.


Study Design
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Study Type : Interventional
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Resting-State Functional MRI in Glioma Patients Before and After Surgery
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : October 24, 2019
Estimated Study Completion Date : October 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (fMRI, CVR MRI, rs-fMRI)
Patients undergo standard of care fMRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.
 Procedure: Functional Magnetic Resonance Imaging
Undergo fMRI
Other Names:
  • fMRI
  • Functional MRI

Procedure: Magnetic Resonance Imaging
Undergo CVR MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging
Undergo rs-fMRI
Other Names:
  • Resting fcMRI
  • Resting State Functional Connectivity MRI
  • RS-fcMRI


Outcome Measures
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Primary Outcome Measures :
  1. Detectability of language networks [ Time Frame: Up to 6 weeks ]
    Will be performed using resting-state-functional magnetic resonance imaging (rs-fMRI). The receiver operating characteristic (ROC) analysis will be carried out to compare the difference between the diagnostic performance of the proposed method and that of the data-driven rs-fMRI method. The study will evaluate the performance of rs-fMRI by comparing with the standard of care intraoperative direct cortical stimulation.


Secondary Outcome Measures :
  1. Changes in resting-state functional connectivity and neuropsychological outcomes [ Time Frame: Up to 6 weeks ]
    Graph theoretical analysis and large-scale network analysis will be applied to analyze pre- and post- surgical rs-fMRI data, to explore how the functional reorganization is correlated to the changes of neuropsychological scores. Correlational analyses will be conducted to determine the associations between changes in rs-fMRI network features and neuropsychological functioning from the pre- to postoperative period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed brain mass suspected to be gliomas
  • Native English speaker
  • Right handed
  • Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language
  • No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist
  • Patients who will undergo neurosurgical resection
  • Patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care
  • Patients who will complete pre- and postoperative neuropsychological testing per standard of care

Exclusion Criteria:

  • Patients with prior radiation or chemotherapy
  • Patients cannot give informed consent
  • Patients cannot undergo MRI and functional MRI examinations
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): NCT03964909


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ho-Ling A. Liu    713-563-7383    hlaliu@mdanderson.org   
Principal Investigator: Ho-Ling A. Liu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ho-Ling A Liu M.D. Anderson Cancer Center
More Information
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Additional Information:
MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03964909     History of Changes
Other Study ID Numbers: 2016-0906
NCI-2019-02653 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0906 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue