Prospective Use of Philips iSuite for Interventional Procedures

Not Applicable

• Conditions: Tumor; Cancer
• Interventions: Device: MRI guided procedure software evaluation

• Registration Number: NCT03432936
• Lead Sponsor: Mayo Clinic

Brief Summary

This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.

Detailed Description

The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures.

The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Study Start: 2021-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI guided procedure software evaluation	MRI guided procedure software evaluation	Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement.

Primary Outcome Measures

Name	Time	Method
Needle placement efficiency into target lesion	Will assess for 3 years with interval assessment each year	Needle placement efficiency record time to final needle position, and compare overall similarity of use with current CT guided intervention during the interventional procedure in order to determine how the iSuite may facilitate intervention with the MRI environment. Each operator will fill out a short questionnaire after each intervention.

Secondary Outcome Measures

Name	Time	Method
Software ease of use in targeting lesion for treatment	Will assess for 3 years with interval assessment each year	Evaluate the ease of use of the software for needle placement

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States