Cranial Nerves Tractography

Not Applicable

Recruiting

• Conditions: Cranial Nerve Palsy
• Interventions: Procedure: preoperative cerebral MRI and operative findings

• Registration Number: NCT02978911
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.

Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-12
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-07-12
• Study Completion: 2026-07-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients who present a skull base tumor that requires surgical removal
• Patients adult, informed and agreed

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Exclusion Criteria

• Pregnant women
• Patients under 18 years old, unable to legally consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skull base tumors	preoperative cerebral MRI and operative findings	Patients who presented a skull base tumor that requires a surgical removal

Primary Outcome Measures

Name	Time	Method
Correlation between the expected and the real position of the selected cranial nerve	at 3 months	Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.

Secondary Outcome Measures

Name	Time	Method
postoperative cranial nerve palsy	at 3 months	comparison with preoperative status

Trial Locations

Locations (1)

Service de Neurologie B, Hôpital Neurologique, HCL; 🇫🇷 Bron, France