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Cranial Nerves Tractography (CN Tracto)

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ClinicalTrials.gov Identifier: NCT02978911
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cranial Nerve Palsy Procedure: preoperative cerebral MRI and operative findings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy
Actual Study Start Date : July 12, 2016
Estimated Primary Completion Date : July 12, 2020
Estimated Study Completion Date : July 12, 2020

Arm Intervention/treatment
Experimental: Skull base tumors
Patients who presented a skull base tumor that requires a surgical removal
Procedure: preoperative cerebral MRI and operative findings



Primary Outcome Measures :
  1. Correlation between the expected and the real position of the selected cranial nerve [ Time Frame: Date of preoperative MRI (<3 months before the surgery) ]
    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.

  2. Correlation between the expected and the real position of the selected cranial nerve [ Time Frame: 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 :
  1. postoperative cranial nerve palsy [ Time Frame: at 3 months ]
    comparison with preoperative status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978911


Contacts
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Contact: Timothée Jacquesson, MD 472356921 ext +33 timothee.jacquesson@neurochirurgie.fr

Locations
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France
Service de Neurologie B, Hôpital Neurologique, HCL Recruiting
Bron, France, 69500
Contact: Timothée Jacquesson, MD    472356921 ext +33    timothee.jacquesson@neurochirurgie.fr   
Principal Investigator: Timothée Jacquesson, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Timothée Jacquesson, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02978911     History of Changes
Other Study ID Numbers: 69HCL16_0759
2015-A01113-46 ( Other Identifier: ID-RCB )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
RMI
Additional relevant MeSH terms:
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Cranial Nerve Diseases
Nervous System Diseases