Status:

RECRUITING

A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain

Lead Sponsor:

M.D. Anderson Cancer Center

Conditions:

Brain Tumor

Eligibility:

All Genders

18+ years

Brief Summary

Our preliminary work demonstrates that an integrated fMRI software solution, incorporating tb-fMRI, rs-fMRI, and CVR mapping, is clinically feasible and helps clinicians plan brain tumor resection. We...

Detailed Description

Primary Objectives: To validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research: We will test the non-infe...

Eligibility Criteria

Inclusion criteria:

  1. patient must be >/= 18 years of age;
  2. patients who will undergo neurosurgical resection of brain tumors;
  3. patients who will undergo presurgical fMRI as standard of care;
  4. patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care.

For the retrospective study, we will review up to 1600 patients all clinical presurgical fMRI studies performed on brain tumor patients at the MD Anderson since 5/2004.

The inclusion criteria:

  1. patients must be >/= 18 years of age;
  2. patients who had the presurgical fMRI that contained at least one task-based fMRI scan.

Exclusion Criteria:

Exclusion criteria for the prospective study:

  1. patients cannot give informed consent;
  2. patients cannot undergo MRI examinations;
  3. patients who are indicated for speech fMRI only but cannot comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.

Exclusion criteria for the retrospective study:

  1. all fMRI scans were contaminated by head motions (translation > 2 mm or rotation > 2 degrees);
  2. only speech fMRI paradigms were performed, and patients were not able to comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.

Key Trial Info

Start Date :

May 23 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 30 2026

Estimated Enrollment :

1720 Patients enrolled

Trial Details

Trial ID

NCT05342454

Start Date

May 23 2022

End Date

November 30 2026

Last Update

November 14 2025

Active Locations (1)

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1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain | DecenTrialz