NCT04880226

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
18mo left

Started Aug 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Aug 2021Dec 2027

First Submitted

Initial submission to the registry

May 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

May 6, 2021

Last Update Submit

January 5, 2026

Conditions

Keywords

MRI-guided biopsy and/or ablation procedure

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

OTHER

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)

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.

Device: Magnetic Resonance Imaging (MRI)

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.

Healthy VolunteersPatients receiving MRI-guided procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aiming Lu, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Desirae Howe-Clayton

CONTACT

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

Locations