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OpenTrials
Enrolling by Invitation

NCT Number: NCT03432936

Prospective Use of Philips iSuite for Interventional Procedures

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.

Enrolling by Invitation

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Key information

Conditions

Cancer Neoplasms Tumor

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients already scheduled for a percutaneous MR guided procedure

Exclusion criteria

  • Pregnant Women

Treatment and study plan

MRI guided procedure software evaluation

Device

MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.

Primary outcomes

  1. Needle placement efficiency into target lesion

    Time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)

    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 outcomes

  1. Software ease of use in targeting lesion for treatment

    Time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)

    Evaluate the ease of use of the software for needle placement

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Philips Healthcare

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2018
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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