RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-23

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05342454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Contact

Ho-Ling Liu, PhD

CONTACT

(713) 563-7383

hlaliu@mdanderson.org

Principal Investigator

Ho-Ling Liu, PhD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ho-Ling Liu, PhD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-23

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2022-05-23

Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

Brain Tumor