NCT06470711

Brief Summary

This study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2024

Typical duration 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 Progress54%
Sep 2024Sep 2027

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 13, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

June 18, 2024

Last Update Submit

January 30, 2026

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

  • Identify diffusion MRI metrics [using conductivity tensor imaging (CTI)] that inform of regional electrical properties in the brain

    At least 4 normal white matter regions of the brain will be analyzed. Fractional anisotropy (FA) and optimized diagnostic imaging (ODI) values will be compared to determine alignment within normal healthy white matter tracts (e.g. cortical spinal tract, corpus callosum).

    Baseline

Study Arms (1)

Observational

Participants complete a survey and undergo MRI on study.

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

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

Healthy volunteers and clinical neuro-oncology subjects with high grade glioma

You may qualify if:

  • Aim 1: normal healthy volunteers
  • Aim 2, 3, 4: participants included in IRB 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma

You may not qualify if:

  • Healthy volunteer unable to have an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Leland S. Hu, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

September 13, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

US(1)