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NCT04302857 Clinical Trial

Tractography Pilot Study Leipzig

Intracranial Neoplasm Clinical Trial

Official title:
Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04302857
Other study ID # 322/19-ek
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information
Verified date June 2022
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.

Description:

Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - intracranial lesion - elective neurosurgical procedure Exclusion Criteria: - MRI not applicable - cerebral ischemia during study period - pregnancy during study period - encephalitis during study period - spontaneous intracerebral hemorrhage during study period

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• routine MRI
MRI with routine DTI sequence

Locations
Country Name City State
Germany Leipzig University Hospital, Department of Neurosurgery Leipzig Sachsen

Sponsors (1)
Lead Sponsor Collaborator
Tim Wende

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurological Performance Neurological Performance Score (NPS) three months
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