Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
- Conditions
- Vascular Malformations
- Interventions
- Device: Image guided needle placement
- Registration Number
- NCT02991352
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
Treatment of vascular malformations requires the placement of a needle within anatomically non well defined, pathological vessels, which may be as small as 1 mm, with the current state of the art relying exclusively on two dimensional fluoroscopy images for guidance. The investigators hypothesize that the combination of stereotactic image guidance with existing targeting methods will result in faster and more reproducible needle placements.
- Detailed Description
This prospective study aims to investigate the feasibility of the utilization of stereotactic image guidance technology for the needle based percutaneous treatment of peripheral vascular malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use with needle based procedures in combination with medical image data including MRI data, as required by this study.
Utilizing feedback from the stereotactic image guidance system, the interventionalist will attempt to place the needle within the malformation. The position and orientation of the needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The position of the needle relative to the desired position within the malformation will be evaluated utilizing fluoroscopy.
If necessary the position of the needle will be adjusted, this adjustment can be performed utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the physician. The final position of the needle will be confirmed on intra-operative DSA imaging and the sclerosant will be applied according to standard clinical protocols.
This single-centre pilot study will involve a total of 10 patients suffering from peripheral vascular malformations. Only non-emergency adult patients will be considered for inclusion in this trial. Inclusion will be at the discretion of the treating physician and patient. As the study is designed as a pilot trial, no comparator is considered and no blinding performed. The trial will be performed over a period of nine months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Patients with venous or mixed venous-lymphatic malformation
- Patients which are regular scheduled for a percutaneous treatment of a vascular malformation
- Informed Consent as documented by signature
- Age < 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Image guided needle placement Image guided needle placement into vascular malformations based on MRI
- Primary Outcome Measures
Name Time Method Time to reach the target During the intervention (duration approx. 90 minutes on average) Time from start of targeting to alcohol embolization in minutes
- Secondary Outcome Measures
Name Time Method Contrast agent volume During the intervention (duration approx. 90 minutes on average) Measured by the nurses in milliliter
Reason to change to standard approach During the intervention (duration approx. 90 minutes on average) Asked by the investigator
System Usability Score (SUS) Directly after the intervention (60 minutes afterwards at the latest) Filled out by the interventionalist
Radiation time During the intervention (duration approx. 90 minutes on average) Measured by the C-arm imaging device in seconds
Radiation dose During the intervention (duration approx. 90 minutes on average) Measured by the C-arm imaging device in μGym²
Number of attempts During the intervention (duration approx. 90 minutes on average) Defined as number of skin punctures, counted by the investigator
Trial Locations
- Locations (3)
Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
🇨🇭Bern, Switzerland
Universitätsklinik für Angiologie
🇨🇭Bern, Switzerland
ARTORG Center for Biomedical Engineering
🇨🇭Bern, Switzerland