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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Skull base tumors
Patients who presented a skull base tumor that requires a surgical removal
Procedure: preoperative cerebral MRI and operative findings
- 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.
- 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.
- postoperative cranial nerve palsy [ Time Frame: at 3 months ]comparison with preoperative status
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
|Contact: Timothée Jacquesson, MD||472356921 ext +firstname.lastname@example.org|
|Service de Neurologie B, Hôpital Neurologique, HCL||Recruiting|
|Bron, France, 69500|
|Contact: Timothée Jacquesson, MD 472356921 ext +33 email@example.com|
|Principal Investigator: Timothée Jacquesson, MD|
|Principal Investigator:||Timothée Jacquesson, MD||Hospices Civils de Lyon|