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

Mayo Clinic

Status

Enrolling

Conditions

Healthy

Treatments

Device: Magnetic Resonance Imaging (MRI)

Study type

Interventional

Funder types

Other

Identifiers

NCT04880226

18-010671

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Healthy Volunteers

Other group

Description:

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

Treatment:

Device: Magnetic Resonance Imaging (MRI)

Patients receiving MRI-guided procedures

Experimental group

Description:

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

Treatment:

Device: Magnetic Resonance Imaging (MRI)