Skip to content

In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02455284
Acronym
FIBRATLAS
Enrollment
134
Registered
2015-05-27
Start date
2015-10-31
Completion date
2021-02-28
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Diseases

Keywords

MRI, Tractography, white, physiology, analysis, matter, tracts

Brief summary

White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases. Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.

Interventions

DEVICEMRI

In vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
82 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Prior enrollment in a body donation program * Age ≥ 82 years * Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969) * Distance to one of the participating laboratories ≤ 120km * Able to remain supine in the MR scanner for acquisition duration (60 min), * Affiliation to Social Security * Informed and written consent Non Inclusion Criteria: * Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions) * Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia * Contraindications to MRI * Contraindication to body donation

Exclusion criteria

* Diagnosis on MRI of brain lesions, excepted common age-related changes

Design outcomes

Primary

MeasureTime frameDescription
Reconstructions of the fiber tracts5.5 yearssimilarity indices, such as modified Haussdorf distance, measured on MRI images

Secondary

MeasureTime frameDescription
Number of subjects included in the database5.5 yearsNumber of subjects included in the database
Scores at neuropsychological evaluation5.5 yearsScores at neuropsychological evaluation
In vivo MRI measures obtained from DWI5.5 yearsIn vivo MRI measures obtained from DWI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026