Menu
Recruiting NCT02978911

Cranial Nerves Tractography

No phase Interventional Cranial Nerve Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: preoperative cerebral MRI and operative findings.
Who it may be relevant to
Registry conditions: Cranial Nerve Palsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy

Overview

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.

Interventions

  • Procedure preoperative cerebral MRI and operative findings

Primary outcome measures

  • Correlation between the expected and the real position of the selected cranial nerve [Time frame: 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]
Secondary outcome measures (1)
  • postoperative cranial nerve palsy [Time frame: at 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Service de Neurologie B, Hôpital Neurologique, HCL — Bron

Identifiers

NCT: NCT02978911 · 69HCL16_0759 · 2015-A01113-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗