NCT05342454

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 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. 1.Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas.
  2. 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. 3.Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,720

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
May 2022Nov 2026

First Submitted

Initial submission to the registry

April 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

4.5 years

First QC Date

April 11, 2022

Last Update Submit

May 18, 2026

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For the prospective study we will include 120 patients with brain tumors. 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.

You may qualify if:

  • patient must be \>/= 18 years of age;
  • patients who will undergo neurosurgical resection of brain tumors;
  • patients who will undergo presurgical fMRI as standard of care;
  • 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.
  • patients must be \>/= 18 years of age;
  • patients who had the presurgical fMRI that contained at least one task-based fMRI scan.

You may not qualify if:

  • patients cannot give informed consent;
  • patients cannot undergo MRI examinations;
  • 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.
  • all fMRI scans were contaminated by head motions (translation \> 2 mm or rotation \> 2 degrees);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ho-Ling Liu, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Ling Liu, PhD

CONTACT

(713) 563-7383hlaliu@mdanderson.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 22, 2022

Study Start

May 23, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

US(1)