Clinical trial NCT02991352: Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
Official title: Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Malformations
Keywords: Vascular Malformations
Image Guidance
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2016-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to reach the target
timeFrame: During the intervention (duration approx. 90 minutes on average)
Secondary outcomes:
measure: Radiation time
timeFrame: During the intervention (duration approx. 90 minutes on average)
measure: Radiation dose
timeFrame: During the intervention (duration approx. 90 minutes on average)
measure: Contrast agent volume
timeFrame: During the intervention (duration approx. 90 minutes on average)
measure: Number of attempts
timeFrame: During the intervention (duration approx. 90 minutes on average)
measure: Reason to change to standard approach
timeFrame: During the intervention (duration approx. 90 minutes on average)
measure: System Usability Score (SUS)
timeFrame: Directly after the intervention (60 minutes afterwards at the latest)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: ARTORG Center for Biomedical Engineering
city: Bern
country: Switzerland
facility: Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
city: Bern
country: Switzerland
facility: Universitätsklinik für Angiologie
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Iris Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
References: