Prospective Use of Philips iSuite for Interventional Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Use of Philips iSuite for Interventional Procedures

Conditions
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Cancer, Tumor

Intervention / Treatment
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* Device: MRI guided procedure software evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients already scheduled for a percutaneous MR guided procedure Exclusion criteria: Pregnant Women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: MRI guided procedure software evaluation<br>Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement. | Device: MRI guided procedure software evaluation<br>* MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle placement efficiency into target lesion | 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. | Will assess for 3 years with interval assessment each year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software ease of use in targeting lesion for treatment | Evaluate the ease of use of the software for needle placement | Will assess for 3 years with interval assessment each year |