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Novel Multimodality Imaging for Navigation in Skull Base Surgery (SBN)

15. oktober 2019 opdateret af: University College, London

Novel Multimodality Imaging Techniques for Neurosurgical Planning and Stereotactic Navigation in Lateral Skull Base Surgery: a Feasibility Study

Successful neurosurgery to remove tumours around the base of the skull, such as a vestibular schwannoma, depends on achieving maximal tumour removal whilst preserving crucial neurological functions such as facial movement, and maintaining quality of life.

Current techniques to direct surgery are based on the surgeon's expertise and knowledge of the relevant anatomy, supplemented by the use of electrical recording and stimulation of the facial nerve. However, it is often very difficult to visualise the nerve during surgery and facial nerve paralysis remains a potentially devastating complication of surgery.

Advanced imaging methods may be used to visualise important neural connections in the brain and computer-assisted processing can generate tumour maps from MRI and ultrasound scans. This study aims to utilise these technologies to develop a 3D navigation system for skull base surgery.

This study aims to develop a system that will combine MRI and intraoperative ultrasound imaging to enhance the surgeon's view of the tumour, facial nerve and other surrounding critical structures during surgery. This information will be made available in the navigation system in the operating room so that operations are more precise resulting in better tumour removal rates and fewer complications.

The system will be assessed during the treatment of 20 patients with vestibular schwannoma at the National Hospital for Neurology and Neurosurgery. This feasibility study will validate the different parts of the new system and help us design a future research study to determine its effectiveness in improving patient care.

This project will result in safer and more effective neurosurgery, with potential consequent financial savings for the NHS and the UK, in addition to marked improvements in the quality of life of patients and reduced dependency upon others.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, WC1E 6BT
        • Rekruttering
        • University College London/University College London Hospitals Joint Research Office
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients aged 18 - 85 years with a vestibular schwannoma who are scheduled for surgery and able to provide written informed consent.

Beskrivelse

Inclusion Criteria:

  • Adult patients aged 18-85 years
  • Patients with a vestibular schwannoma who are scheduled for surgery
  • Patients willing and able to provide written informed consent

Exclusion Criteria:

  • Patients aged under 18 years of age or older than 85 years
  • Previous, treated posterior fossa brain tumour(s)
  • Previous ear or facial surgery on ipsilateral side of tumour
  • Neurofibromatosis Type II
  • Participation in other clinical trials
  • Any contraindication for MR imaging
  • Any contraindication for MR contrast agent administration
  • Any contraindication for CT imaging
  • Pregnancy or breast feeding

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
SBN arm
We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images
Enhed: Use of navigation system
Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the functionality and performance of a 3D surgical technical platform for integrating data from 3 different data sources (MRI, US and Neuronavigation data) in a clinical setting using a composite of quantitative and qualitative measurements
Tidsramme: Data will be collected on the date of patients' routine surgical procedure, assessed on 1 day from the start time (hh:hh) of set-up of the 3d surgical platform to the end time (hh:hh) of surgery
Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
Data will be collected on the date of patients' routine surgical procedure, assessed on 1 day from the start time (hh:hh) of set-up of the 3d surgical platform to the end time (hh:hh) of surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
Tidsramme: A minimum of 9 time points (selected at random) during each surgical procedure, assessed on 1 day from the start time (hh:hh) to the end time (hh:hh) of surgery
Stimulation response (binary outcome) and amplitude (mA)
A minimum of 9 time points (selected at random) during each surgical procedure, assessed on 1 day from the start time (hh:hh) to the end time (hh:hh) of surgery
Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement
Tidsramme: Final intraoperative US volume vs post op MRI volume (within 3 months)
Tumour volume (cm3) on MRI and US
Final intraoperative US volume vs post op MRI volume (within 3 months)
Average duration of surgical procedure using 3D navigation system
Tidsramme: From start time to end time of each surgical procedure, assessed on 1 day
Time (hours)
From start time to end time of each surgical procedure, assessed on 1 day
Documentation of technical system issues and implemented solutions
Tidsramme: From start time to end time of each surgical procedure, assessed on 1 day
Documentation of technical system issues and implemented solutions (using qualitative research methods)
From start time to end time of each surgical procedure, assessed on 1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Samarbejdspartnere

University College London Hospitals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2019

Primær færdiggørelse (Forventet)

1. oktober 2020

Studieafslutning (Forventet)

1. maj 2021

Datoer for studieregistrering

Først indsendt

18. september 2019

Først indsendt, der opfyldte QC-kriterier

15. oktober 2019

Først opslået (Faktiske)

16. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 17/0661

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Vestibulær Schwannoma

Kliniske forsøg med Use of navigation system

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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