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Trial record 4 of 21 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | glioma | United States | First posted from 04/01/2019 to 07/31/2019

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

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 27, 2019
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE April 24, 2017
Estimated Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resting-State Functional MRI in Glioma Patients Before and After Surgery
Official Title  ICMJE Resting-State Functional MRI in Glioma Patients Before and After Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Brain Mass
  • Glioma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Functional Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 24, 2019
Estimated Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964909
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ho-Ling A Liu M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP