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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04880226

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Evaluation of Low-risk MRI Sequences for the Purpose of Aiding in MR-guided Ablations	Device: Magnetic Resonance Imaging (MRI)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 30, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy Volunteers 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) 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Other: Healthy Volunteers

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)

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.

Experimental: 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.

Device: Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Aiming Lu, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Aiming Lu, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04880226

Other Study ID Numbers:

18-010671

First Posted:

May 10, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 17, 2021