MRI-Guided Procedure Software for Cancer

Recruiting at 1 trial location

Overseen By Desirae Howe-Clayton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new software that assists doctors in using MRI images to guide needles during cancer procedures, such as biopsies or ablations. The goal is to determine if this software, called Philips Interventional iSuite, enables doctors to place needles more easily and quickly compared to standard MRI methods. It suits patients already scheduled for a procedure involving MRI-guided needle placement. This trial could result in more precise and efficient cancer treatments. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve future cancer care.

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 prior data suggests that this MRI-guided procedure software is safe for use in cancer treatments?

Research shows no specific safety data currently available for the Philips Interventional iSuite software. This software assists doctors in guiding needles during procedures like biopsies (taking a small tissue sample for testing) and ablations (removing unhealthy tissue).

The FDA has not yet cleared the Philips Interventional iSuite software, meaning it isn't officially approved for general medical use. However, studies are underway to determine if it can make these procedures more effective and faster for doctors. Since the software only aids in imaging and doesn't directly interact with the patient, it is expected to be generally safe.

Without direct safety data, the trial's "Not Applicable" phase suggests the software is likely considered low risk, as such software typically doesn't have direct physical effects on the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRI-guided procedure software from Philips because it enhances precision during biopsies and ablations. Unlike standard MRI imaging, this advanced software guides needle placement in real-time, potentially improving accuracy and reducing the risk of complications. By integrating this technology into cancer treatment, clinicians hope to streamline procedures, making them safer and more effective for patients.

What evidence suggests that this MRI-guided procedure software is effective for cancer?

This trial will evaluate the Philips Interventional iSuite software, which studies have shown can enhance needle placement precision during MRI-guided procedures. The software provides live images that assist doctors in guiding needles more accurately for biopsies and treatments like tumor removal. By improving accuracy, it may prevent damage to nearby healthy tissues and increase the procedure's effectiveness. Early signs suggest it could make these procedures faster and more reliable than standard MRI methods. ^{1 4 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Philips Interventional iSuite software

Trial Overview The 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.

How Is the Trial Designed?

Group I: MRI guided procedure software evaluation Experimental Treatment 1 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.

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

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

Philips Healthcare

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting medical device safety incidents to regulatory authorities: An analysis and classification of technology-induced errors. Palojoki, S., Saranto, K., Lehtonen, L.[2020]

A review of the MAUDE database identified 2,837 adverse events related to the Da Vinci Surgical System from 2009 to 2012, with 75% classified as mild and 3% as life-threatening, indicating that while complications can occur, most are not severe.

The study developed a standardized classification system for these events, which showed moderate agreement among surgeons and revealed that urology procedures had more severe complications compared to obstetrics and gynecology procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gupta, P., Schomburg, J., Krishna, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03432936?tab=history&a=1

Prospective Use of Philips iSuite for Interventional Procedures 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/45ed46966cfec7d4/nct03432936-prospective-use-philips-isuite-interventional-procedures

Prospective Use of Philips iSuite for Interventional Procedures 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 ...

3. withpower.com withpower.com/trial/phase-5-2021-4c2d6

MRI-Guided Procedure Software for Cancer 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 ...

4. usa.philips.com usa.philips.com/healthcare/image-guided-therapy/interventional-oncology-suite

Interventional oncology suite Onco suite provides a comprehensive solution for planning and guidance of embolization, as well as for biopsy and ablation procedures.

5. mayo.edu mayo.edu/research/clinical-trials/cls-20383389

Prospective Use of Philips iSuite for Interventional ... 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 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03432936/prospective-use-of-philips-isuite-for-interventional-procedures

Prospective Use of Philips iSuite for Interventional ... The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on ...

7. ajronline.org ajronline.org/doi/10.2214/AJR.15.14732

Closed-Bore Interventional MRI: Percutaneous Biopsies and ... This article reviews the current state of interventional MRI—specifically, percutaneous biopsy and ablation procedures— using closed-bore diagnostic scanners.