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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Malformations
• Intervention / Treatment: Device: Image guided needle placement

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • ARTORG Center for Biomedical Engineering
  • Bern, Switzerland, 3010
    • Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie
  • Bern, Switzerland, 3010
    • Universitätsklinik für Angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Image guided needle placement into vascular malformations based on MRI	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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: Iris Baumgartner, MD, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Vascular Malformations; Image Guidance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Vascular Malformations
• Other Study ID Numbers: 3193; 2016-00827 (Other Identifier: Kantonale Ethikkommission Bern (KEK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No