Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study

Conditions
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Vascular Malformations

Intervention / Treatment
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* Device: Image guided needle placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Image guided needle placement into vascular malformations based on MRI | Device: Image guided needle placement<br>* Stereotactic MRI based image guidance to aid in the placement of percutaneous needles into vascular malformations using a CE marked navigation system (CAS-One IR, CAScination AG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach the target | Time from start of targeting to alcohol embolization in minutes | During the intervention (duration approx. 90 minutes on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation time | Measured by the C-arm imaging device in seconds | During the intervention (duration approx. 90 minutes on average) | 
| Radiation dose | Measured by the C-arm imaging device in μGym² | During the intervention (duration approx. 90 minutes on average) | 
| Contrast agent volume | Measured by the nurses in milliliter | During the intervention (duration approx. 90 minutes on average) | 
| Number of attempts | Defined as number of skin punctures, counted by the investigator | During the intervention (duration approx. 90 minutes on average) | 
| Reason to change to standard approach | Asked by the investigator | During the intervention (duration approx. 90 minutes on average) | 
| System Usability Score (SUS) | Filled out by the interventionalist | Directly after the intervention (60 minutes afterwards at the latest) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Malformations, Image Guidance