- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02978911
Cranial Nerves Tractography (CN Tracto)
Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Timothée Jacquesson, MD
- Phone Number: +33 472356921
- Email: timothee.jacquesson@neurochirurgie.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- Service de Neurologie B, Hôpital Neurologique, HCL
-
Contact:
- Timothée Jacquesson, MD
- Phone Number: +33 472356921
- Email: timothee.jacquesson@neurochirurgie.fr
-
Principal Investigator:
- Timothée Jacquesson, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Skull base tumors
Patients who presented a skull base tumor that requires a surgical removal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Date of preoperative MRI (<3 months before the surgery)
|
|
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.
|
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative cranial nerve palsy
Time Frame: at 3 months
|
comparison with preoperative status
|
at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timothée Jacquesson, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0759
- 2015-A01113-46 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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