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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment. | Device: Magnetic Resonance Imaging (MRI)<br>* 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.<br>|
| Experimental: Patients receiving MRI-guided procedures<br>As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions. | Device: Magnetic Resonance Imaging (MRI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI-guided biopsy and/or ablation procedure