Tractography Pilot Study Leipzig | NCT04302857

Studies
Tractography Pilot Study Leipzig

NCT04302857

Sponsor

Tim Wende

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Intracranial Neoplasm

Interventions

routine MRI

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 6, 2020

First Submission Date that Met QC Criteria

Mar 6, 2020

First Posted Date

Mar 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2022

Last Update Posted Date

Jun 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
routine MRI	Other	MRI with routine DTI sequence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurological Performance	Neurological Performance Score (NPS)	three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Standard cohort of neurosurgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jürgen Meixensberger, MD	University of Leipzig	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leipzig University Hospital, Department of Neurosurgery		Leipzig	Saxony	04103	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37646398	Derived	Wende T, Hoffmann A, Scherlach C, Kasper J, Sander C, Arlt F, Dietel E, Stockert A, Meixensberger J, Prasse G. Preserved White Matter Integrity and Recovery After Brain Tumor Surgery: A Prospective Pilot Study on the Frontal Aslant Tract. Brain Connect. 2023 Dec;13(10):589-597. doi: 10.1089/brain.2023.0033. Epub 2023 Oct 19.

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms