12 Participants Needed

MRI-Guided Procedure Software for Cancer

Recruiting at 1 trial location
DH
Overseen ByDesirae Howe-Clayton
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MRI-Guided Procedure Software for Cancer treatment?

The research on MRI-guided robotic prostate therapy shows that the software can provide precise navigation and real-time imaging, which are important for accurate treatment. This suggests that similar software, like the Philips Interventional iSuite, could also be effective in guiding cancer treatments with precision.12345

What safety data exists for MRI-Guided Procedure Software for Cancer?

The research articles reviewed do not provide specific safety data for MRI-Guided Procedure Software for Cancer or related software like Philips Interventional iSuite. They focus on other medical devices and general safety issues in medical technology.678910

How is the MRI-Guided Procedure Software for Cancer treatment different from other treatments?

The MRI-Guided Procedure Software for Cancer, using Philips Interventional iSuite, is unique because it integrates real-time MRI imaging with robotic assistance to precisely guide procedures, offering interactive target planning and 3D visualization. This approach enhances accuracy and workflow efficiency compared to traditional methods, which may not provide such detailed real-time imaging and robotic precision.13111213

Research Team

DA

David A Woodrum, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients already scheduled to undergo MR-guided procedures like biopsies or ablations, where needles are inserted through the skin. Pregnant women cannot participate in this study.

Inclusion Criteria

I am scheduled for an MRI-guided procedure that does not require surgery.

Exclusion Criteria

Pregnant Women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Guided Procedure

Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations

3 years
Interval assessments each year

Follow-up

Participants are monitored for safety and effectiveness after the MRI guided procedure

4 weeks

Treatment Details

Interventions

  • Philips Interventional iSuite software
Trial OverviewThe study is evaluating new MRI imaging guidance software called Philips Interventional iSuite. It aims to see if this software can help doctors more accurately and quickly position needles during interventional procedures.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MRI guided procedure software evaluationExperimental Treatment1 Intervention
Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Philips Healthcare

Industry Sponsor

Trials
127
Recruited
200,000+
Roy Jakobs profile image

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs profile image

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Findings from Research

A study analyzing 60 reports from the FDA's MAUDE database on radiofrequency ablation (RFA) for leiomyomas found that the most common adverse event was infection, highlighting potential safety concerns with this treatment.
Of the injury cases reviewed, 34.9% required additional surgical intervention, indicating that while RFA is a novel treatment option, there are significant risks that necessitate careful monitoring and postmarket surveillance.
Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database.Young, RJ., Puma, L., Latham, M., et al.[2023]
A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.
The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.
Improving patient safety in the inpatient setting through risk assessment and mitigation.Reche Navarro, MN.[2016]
A review of 138 incident reports from users of electronic health records in Finland revealed that vulnerabilities in these systems can lead to serious harm across various healthcare settings.
The low rate of reported incidents suggests significant challenges in the oversight of medical software and highlights potential barriers to effective reporting of adverse events.
Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors.Palojoki, S., Saranto, K., Lehtonen, L.[2020]

References

Application of open source image guided therapy software in MR-guided therapies. [2021]
Development of Mobile Application for Dynamically Monitoring the Risk of Prostate Cancer and Clinicopathology. [2022]
Software strategy for robotic transperineal prostate therapy in closed-bore MRI. [2019]
The utilization of magnetic resonance imaging in the operating room. [2022]
A computer program for I-125 seed implant. [2004]
Radiofrequency Ablation for Treatment of Leiomyomas: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database. [2023]
Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]
Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. [2020]
Development of a Classification Scheme for Examining Adverse Events Associated with Medical Devices, Specifically the DaVinci Surgical System as Reported in the FDA MAUDE Database. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Real-World Complications of the SpaceOAR Hydrogel Spacer: A Review of the Manufacturer and User Facility Device Experience Database. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Rapid freehand MR-guided percutaneous needle interventions: an image-based approach to improve workflow and feasibility. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
MRI-guided procedures in various regions of the body using a robotic assistance system in a closed-bore scanner: preliminary clinical experience and limitations. [2010]
13.United Statespubmed.ncbi.nlm.nih.gov
Integration of interventional MRI with computer-assisted surgery. [2019]