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NCT04880226 Clinical Trial

A Study to Evaluate Non-significant Risk Operation Magnetic Resonance Imaging for MRI Guided Ablation

Healthy Clinical Trial

Official title:
Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation Using the Philips MRI

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04880226
Other study ID # 18-010671
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date December 2024

Study information
Verified date September 2023
Source Mayo Clinic
Contact Desirae Howe-Clayton
Phone 507-255-0111
Email howe.desirae@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.

Description:

This proposal includes evaluation of advanced MR imaging methods in the iMRI environment and will operate within the NSR guidelines for data acquisition established by the FDA/CDRH. The significant testing by vendor and Mayo staff prior to in vivo use, assure the safety of these studies and overall system stability. The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female. - Age = 18 years. - Healthy volunteers or patients already scheduled for a MR-guided procedure. Exclusion Criteria: - Individuals 18 years of age. - Pregnant women.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Magnetic Resonance Imaging (MRI)
Ongoing evaluations of magnetic resonance imaging (MRI) using the Philips Ingenua 1.5T scanner associated with MRI-guided procedures (e.g. ablations or biopsies) are essential to continued procedure improvement within the newly-built hybrid procedure suite.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical determination whether the sequence improves patient care during MRI-guided procedures. It will be determined whether the sequence under investigation improves one of the following: 1. lesion targeting (e.g. better guidance of applicators by reduction of metal artifact), 2. lesion ablation (e.g. improved MR thermometry, visualization of cryoablation ice), or 3. accurate assessment of treatment outcome (e.g. margins of ablation relative to lesion boundaries. 3 years
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