Cranial Nerves Tractography

NCT ID: NCT02978911

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-12
• Study Completion Date: 2026-07-12

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.

Conditions

Cranial Nerve Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Skull base tumors

Patients who presented a skull base tumor that requires a surgical removal

Group Type: EXPERIMENTAL

preoperative cerebral MRI and operative findings

Intervention Type: PROCEDURE

Interventions

preoperative cerebral MRI and operative findings

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothée Jacquesson, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de Neurologie B, Hôpital Neurologique, HCL

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Timothée Jacquesson, MD

Role: CONTACT

timothee.jacquesson@neurochirurgie.fr

472356921 ext. +33

Facility Contacts

Timothée Jacquesson, MD

Role: primary

timothee.jacquesson@neurochirurgie.fr

472356921 ext. +33

Other Identifiers

2015-A01113-46

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0759

Identifier Type: -

Identifier Source: org_study_id