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Active, not recruitingNCT05215132Avery HSUpdated Sep 15, 2026

Investigational MRI Clinical Software and Hardware

A Phase 4 interventional study of MRI and Gadavist 2Ml Solution for Injection in Image, Body, sponsored by Northwestern University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Northwestern University · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Dec 2019, registered Jun 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
2,000
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Image, Body

Keywords

  • MRI hardware testing
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Other
    Patient w/ Contrast

    Patients will add 15 minutes to their SOC MRI for research purposes

    Radiation: MRI · Drug: Gadavist 2Ml Solution for Injection

  • Other
    Patient no contrast

    Patients will add 15 minutes to their SOC MRI for research purposes

    Radiation: MRI

  • Other
    Volunteer w/ contrast

    Volunteers undergo 1 research MRI for research purposes

    Radiation: MRI · Drug: Gadavist 2Ml Solution for Injection

  • Other
    Volunteer no contrast

    Volunteers undergo 1 research MRI for research purposes

    Radiation: MRI

Interventions

  • RadiationMRI

    1.5T or 3T MRI scanner (Siemens Medical Systems)

  • DrugGadavist 2Ml Solution for Injection

    Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)

06

What researchers measure

Primary outcomes

  1. Conduct clinical protocol development and validation

    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.

    Time frame: 5 years

Secondary outcomes

  1. Demonstrate and train

    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.

    Time frame: 5 years

07

Study locations

1 site
  • Northwestern University- Feinberg School of Medicine
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05215132
Lead sponsor
Northwestern University
Responsible party
Ryan Avery (Associate Professor, Northwestern University) — Principal investigator
First posted
Jan 31, 2022
Start date
Dec 19, 2019
Primary completion
Jan 31, 2028 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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