NCT03432936

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable cancer

Timeline
8mo left

Started Jun 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jun 2021Dec 2026

First Submitted

Initial submission to the registry

January 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
3.3 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

January 2, 2018

Last Update Submit

March 26, 2026

Conditions

CancerTumor

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Software ease of use in targeting lesion for treatment

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

Study Arms (1)

MRI guided procedure software evaluation

EXPERIMENTAL

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

Interventions

MRI guided procedure software evaluationDEVICE

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

MRI guided procedure software evaluation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients already scheduled for a percutaneous MR guided procedure

You may not qualify if:

  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • David A Woodrum, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2018

First Posted

February 14, 2018

Study Start

June 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)