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

NCT ID: NCT04880226

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2027-12-31

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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

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.

Patients receiving MRI-guided procedures

As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Aiming Lu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiming Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Desirae Howe-Clayton

Role: CONTACT

507-255-0111

Other Identifiers

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18-010671

Identifier Type: -

Identifier Source: org_study_id

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