- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04128345
Novel Multimodality Imaging for Navigation in Skull Base Surgery (SBN)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Suzanne Emerton
- Numéro de téléphone: 00 44 20 3447 7428
- E-mail: semerton@nhs.net
Lieux d'étude
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London, Royaume-Uni, WC1E 6BT
- Recrutement
- University College London/University College London Hospitals Joint Research Office
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Contact:
- Misha Ladva
- Numéro de téléphone: 02034475199
- E-mail: randd@ucl.ac.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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SBN arm
We will evaluate the feasibility of using an integrated navigation system incorporating pre-operative MRI and intraoperative ultrasound images
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Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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
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Composite of quantitative and qualitative measurements to assess the system's functionality and technical performance
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation of electromyographic stimulation of facial nerve with preoperatively acquired diffusion imaging
Délai: 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
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Stimulation response (binary outcome) and amplitude (mA)
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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
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Postoperative tumour volume on contrast-enhanced MRI and its correlation with the final intraoperative ultrasound measurement
Délai: Final intraoperative US volume vs post op MRI volume (within 3 months)
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Tumour volume (cm3) on MRI and US
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Final intraoperative US volume vs post op MRI volume (within 3 months)
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Average duration of surgical procedure using 3D navigation system
Délai: From start time to end time of each surgical procedure, assessed on 1 day
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Time (hours)
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From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions
Délai: From start time to end time of each surgical procedure, assessed on 1 day
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Documentation of technical system issues and implemented solutions (using qualitative research methods)
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From start time to end time of each surgical procedure, assessed on 1 day
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Tumeurs oto-rhino-laryngologiques
- Maladies oto-rhino-laryngologiques
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Maladies de l'oreille
- Tumeurs du système nerveux
- Maladies des nerfs crâniens
- Tumeurs neuroendocrines
- Tumeurs de la gaine nerveuse
- Tumeurs du système nerveux périphérique
- Tumeurs des nerfs crâniens
- Névrome
- Maladies du nerf vestibulocochléaire
- Maladies rétrocochléaires
- Neurilemmome
- Névrome, Acoustique
Autres numéros d'identification d'étude
- 17/0661
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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