HealthyNCT04880226
A Study to Evaluate Non-significant Risk Operation Magnetic Resonance Imaging for MRI Guided Ablation
A study testing Magnetic Resonance Imaging (MRI) in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female.
- Age ≥ 18 years.
- Healthy volunteers or patients already scheduled for a MR-guided procedure.
Who cannot join
- Individuals 18 years of age.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation Using the Philips MRI
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.
Read the 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.
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
- Healthy
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- MRI-guided biopsy and/or ablation procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment. Receives: Device: Magnetic Resonance Imaging (MRI) |
| Patients receiving MRI-guided procedures | Experimental | As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions. Receives: Device: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start30 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiming Lu, Mayo Clinic
- Investigators
- Aiming Lu, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880226
- Sponsor's protocol ID
- 18-010671
- Status last verified
- Jan 2026
- First submitted
- 6 May 2021
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non Significant Risk Operation Magnetic Resonance Imaging for MR Guided Ablation Using the Philips MRI
- ClinicalTrials.gov ID
- NCT04880226
- Acronym / sponsor ID
- 18-010671
- Conditions
- Healthy
- Keywords
- MRI-guided biopsy and/or ablation procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Device: Magnetic Resonance Imaging (MRI)Imaging 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 | Experimental | Device: Magnetic Resonance Imaging (MRI)As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female.
- Age ≥ 18 years.
- Healthy volunteers or patients already scheduled for a MR-guided procedure.
Key exclusion criteria (2 listed)
- Individuals 18 years of age.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy Volunteers, Patients receiving MRI-guided procedures |
Primary outcome
Clinical determination whether the sequence improves patient care during MRI-guided procedures.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aiming Lu, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desirae Howe-Clayton (507-255-0111, howe.desirae@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical determination whether the sequence improves patient care during MRI-guided procedures. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.