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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT04880226
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-10
• Study Start: 2021-08-30
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female.
• Age ≥ 18 years.
• Healthy volunteers or patients already scheduled for a MR-guided procedure.

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Exclusion Criteria

• Individuals 18 years of age.
• Pregnant women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving MRI-guided procedures	Magnetic Resonance Imaging (MRI)	As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions.
Healthy Volunteers	Magnetic Resonance Imaging (MRI)	Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment.

Primary Outcome Measures

Name	Time	Method
Clinical determination whether the sequence improves patient care during MRI-guided procedures.	3 years	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States