Investigational MRI Clinical Software and Hardware (Avery HS)

April 21, 2026 updated by: Ryan Avery, Northwestern University

Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software

Patients and healthy volunteers will be scanned in order to test new sequences.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aims of this study are to:

  1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
  2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • At least 18 years of age

    • Able to complete the MR safety questionnaire.
    • Able to comprehend and provide informed consent in English.
    • When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
    • When contrast is being administered: patients with a GFR ≥30 ml/min

Exclusion Criteria:

  • • When contrast is being administered: subjects with a GFR < 30 ml/min

    • When contrast is being administered: subjects with acute kidney injury
    • When contrast is administered, allergy to gadolinium-containing contrast media
    • Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
    • Adults unable to consent
    • Individuals who are not yet adults
    • Pregnant or breastfeeding women
    • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient w/ Contrast
Patients will add 15 minutes to their SOC MRI for research purposes
Radiation: MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Drug: Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Other: Patient no contrast
Patients will add 15 minutes to their SOC MRI for research purposes
Radiation: MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Other: Volunteer w/ contrast
Volunteers undergo 1 research MRI for research purposes
Radiation: MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Drug: Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Other: Volunteer no contrast
Volunteers undergo 1 research MRI for research purposes
Radiation: MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conduct clinical protocol development and validation
Time Frame: 5 years
Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate and train
Time Frame: 5 years
Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU#00211312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research team may use the data obtained from this study for future institutionally approved studies not yet identified but conducted by Feinberg School of Medicine investigators. This means that information about you, including your name, date of birth, study data, etc. may be given to investigators not currently working on this study.

IPD Sharing Time Frame

5 years

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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