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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05342454
Other study ID # 2021-0791
Secondary ID NCI-2022-00369
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2022
Est. completion date November 30, 2026

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Ho-Ling Liu, PhD
Phone (713) 563-7383
Email hlaliu@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 have developed a novel automated seed selection method that can accurately map language networks from rs-fMRI. We hypothesize that our innovative approach to enhance, optimize, and validate our preliminary software and integrate it with an established fMRI platform will create robust solutions for clinical RSN and CVR mapping. Partnering with NordicNeuroLab (NNL) will leverage the professional software development by a seasoned commercial MRI software producer in coordination with leading clinical and research experts at MD Anderson. The research will be conducted through three specific aims: 1. Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas. 2. Develop a clinical software platform for mapping CVR and determine optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results. 3. Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.


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-inferiority of rs-fMRI comparing to task-based fMRI (tb-fMRI) by using intra-operative direct cortical stimulation as the gold standard. To test whether CVR mapping using the software developed in this research will increase confidence of fMRI mapping of language and motor (hand and tongue) areas: We will test whether the accuracy of fMRI, assessed by using intra-operative direct cortical stimulation as the gold standard, will improve after incorporating the CVR mapping. Secondary Objectives: To optimize the rs-fMRI and CVR mapping software during the development phases and to test feasibility of the post-processing workflow using clinical images.


Recruitment information / eligibility

Status Recruiting
Enrollment 1720
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research. Through study completion, an average of 1 year
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