Cranial Nerve Palsy Clinical Trial
— CN TractoOfficial title:
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | July 12, 2026 |
| Est. primary completion date | July 12, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Neurologie B, Hôpital Neurologique, HCL | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between the expected and the real position of the selected cranial nerve | 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) | |
| Primary | Correlation between the expected and the real position of the selected cranial nerve | 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 | postoperative cranial nerve palsy | comparison with preoperative status | at 3 months |