Use of DTT to Define Facial Nerve Position in Vestibular Schwannomas

NCT04057976 | Completed

• 1 other identifier: 226479
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular schwannomas (VS) arise from the vestibulocochlear (hearing and balance) nerve, located at the base of the brain. Although benign, VS can enlarge over time, resulting in debilitating symptoms; therefore, surgical removal is frequently offered. One significant risk of surgery is inadvertent injury to the facial nerve, which lies adjacent to the vestibulocochlear nerve. Currently, the nerve's course is only revealed during surgical dissection and injury can cause permanent facial weakness. It would therefore be useful for the surgeon to know the course of the nerve before operating. To this end, a new MRI technique known as probabilistic diffusion tensor tractography (DTT) has shown potential in revealing the course of the facial nerve pre-operatively. However, its clinical reliability remains uncertain. This study aims to investigate the reliability of DTT in identifying the course of the facial nerve preoperatively in patients undergoing surgery for VS. The future benefit would be to enable surgeons to operate with more confidence and potentially reduce the chance of nerve injury. The study will recruit adult patients due to have surgery for VS. The only change to the participants' clinical pathways will be the addition of a DTT sequence to their pre-operative MRI scans (increasing scanning time by approximately 10 minutes).

Conditions

Vestibular Schwannoma

Outcome Measures

Primary Outcomes (1)

• Accuracy of probabilistic diffusion tensor tractography (DTT)

  To assess the accuracy of pre-operative probabilistic DTT in determining the position of the facial nerve (relative to extrameatal portion of a vestibular schwannoma) by using the facial nerve position at surgery as a reference standard.

  4 years

Secondary Outcomes (6)

• Reproducibility

  4 years

• Relationship of tumour size with confidence

  4 years

• Relationship of tumour size with accuracy

  4 years

• Facial nerve shape

  4 years

• Comparison of DTT with conventional anatomical sequence

  4 years

Study Arms (1)

Patients having pre-operative DTT prior to surgery

EXPERIMENTAL

All patients in this study will undergo DTT as part of a pre-operative MRI.

Diagnostic Test: Probabilistic diffusion tensor tractography

Interventions

Probabilistic diffusion tensor tractography DIAGNOSTIC_TEST

Patients enrolled in this study will undergo probabilistic diffusion tensor tractography (additional MRI sequence) preoperatively in order to determine whether this it is possible to determine the course of the facial nerve.

Patients having pre-operative DTT prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The capacity to understand the patient information sheet and the ability to provide written informed consent
• \>1.5cm extrameatal tumor determined to represent a vestibular schwannoma by preoperative imaging
• HB grade I or II preoperatively

You may not qualify if:

• Standard contraindications to MRI
• Previous cranial radiotherapy or previous surgery to the cerebellopontine angle cistern or IAM

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, London, SE5 9RS, United Kingdom

Location

Related Publications (9)

• Cauley KA, Filippi CG. Diffusion-tensor imaging of small nerve bundles: cranial nerves, peripheral nerves, distal spinal cord, and lumbar nerve roots--clinical applications. AJR Am J Roentgenol. 2013 Aug;201(2):W326-35. doi: 10.2214/AJR.12.9230.

  PMID: 23883249 BACKGROUND

• Choi KS, Kim MS, Kwon HG, Jang SH, Kim OL. Preoperative identification of facial nerve in vestibular schwannomas surgery using diffusion tensor tractography. J Korean Neurosurg Soc. 2014 Jul;56(1):11-5. doi: 10.3340/jkns.2014.56.1.11. Epub 2014 Jul 31.

  PMID: 25289119 BACKGROUND

• Gerganov VM, Giordano M, Samii M, Samii A. Diffusion tensor imaging-based fiber tracking for prediction of the position of the facial nerve in relation to large vestibular schwannomas. J Neurosurg. 2011 Dec;115(6):1087-93. doi: 10.3171/2011.7.JNS11495. Epub 2011 Aug 26.

  PMID: 21962081 BACKGROUND

• Mukherjee P, Berman JI, Chung SW, Hess CP, Henry RG. Diffusion tensor MR imaging and fiber tractography: theoretic underpinnings. AJNR Am J Neuroradiol. 2008 Apr;29(4):632-41. doi: 10.3174/ajnr.A1051. Epub 2008 Mar 13.

  PMID: 18339720 BACKGROUND

• Sampath P, Rini D, Long DM. Microanatomical variations in the cerebellopontine angle associated with vestibular schwannomas (acoustic neuromas): a retrospective study of 1006 consecutive cases. J Neurosurg. 2000 Jan;92(1):70-8. doi: 10.3171/jns.2000.92.1.0070.

  PMID: 10616085 BACKGROUND

• Song F, Hou Y, Sun G, Chen X, Xu B, Huang JH, Zhang J. In vivo visualization of the facial nerve in patients with acoustic neuroma using diffusion tensor imaging-based fiber tracking. J Neurosurg. 2016 Oct;125(4):787-794. doi: 10.3171/2015.7.JNS142922. Epub 2016 Jan 1.

  PMID: 26722859 BACKGROUND

• Taoka T, Hirabayashi H, Nakagawa H, Sakamoto M, Myochin K, Hirohashi S, Iwasaki S, Sakaki T, Kichikawa K. Displacement of the facial nerve course by vestibular schwannoma: preoperative visualization using diffusion tensor tractography. J Magn Reson Imaging. 2006 Nov;24(5):1005-10. doi: 10.1002/jmri.20725.

  PMID: 17031835 BACKGROUND

• Zhang Y, Mao Z, Wei P, Jin Y, Ma L, Zhang J, Yu X. Preoperative Prediction of Location and Shape of Facial Nerve in Patients with Large Vestibular Schwannomas Using Diffusion Tensor Imaging-Based Fiber Tracking. World Neurosurg. 2017 Mar;99:70-78. doi: 10.1016/j.wneu.2016.11.110. Epub 2016 Nov 30.

  PMID: 27915063 BACKGROUND

• Zolal A, Juratli TA, Podlesek D, Rieger B, Kitzler HH, Linn J, Schackert G, Sobottka SB. Probabilistic Tractography of the Cranial Nerves in Vestibular Schwannoma. World Neurosurg. 2017 Nov;107:47-53. doi: 10.1016/j.wneu.2017.07.102. Epub 2017 Jul 25.

  PMID: 28754643 BACKGROUND

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Steve Connor, MBBS, FRCR

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 15, 2019
• Study Start: June 27, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)