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

Vascular Malformations Clinical Trial

— SIGVaM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991352
• Other study ID #: 3193
• Secondary ID: 2016-00827
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 13, 2017
• Start date: March 21, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: December 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Malformations

Intervention

Device:
• Image guided needle placement
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)

Locations

Country	Name	City	State
Switzerland	ARTORG Center for Biomedical Engineering	Bern
Switzerland	Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie	Bern
Switzerland	Universitätsklinik für Angiologie	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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