A Study to Evaluate Non-significant Risk Operation Magnetic Resonance Imaging for MRI Guided Ablation
Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation Using the Philips MRI
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Aug 2021
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 7, 2026
January 1, 2026
5.3 years
May 6, 2021
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Healthy Volunteers
OTHERImaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment.
Patients receiving MRI-guided procedures
EXPERIMENTALAs described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female.
- Age ≥ 18 years.
- Healthy volunteers or patients already scheduled for a MR-guided procedure.
You may not qualify if:
- Individuals 18 years of age.
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aiming Lu, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 10, 2021
Study Start
August 30, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01