Investigational MRI Clinical Software and Hardware

NCT05215132 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: STU#00211312
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Image, Body

Keywords

MRI hardware testing

Outcome Measures

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.

  5 years

Secondary Outcomes (1)

• Demonstrate and train

  5 years

Study Arms (4)

Patient w/ Contrast

OTHER

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

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

Patient no contrast

OTHER

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

Radiation: MRI

Volunteer w/ contrast

OTHER

Volunteers undergo 1 research MRI for research purposes

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

Volunteer no contrast

OTHER

Volunteers undergo 1 research MRI for research purposes

Radiation: MRI

Interventions

MRI RADIATION

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

Patient no contrast; Patient w/ Contrast; Volunteer no contrast; Volunteer w/ contrast

Gadavist 2Ml Solution for Injection DRUG

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

Patient w/ Contrast; Volunteer w/ contrast

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University- Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

gadobutrol; Solutions; Injections

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Emily Powell

CONTACT

312.695.2956; emily.powell@northwestern.edu

Saira Jahangir

CONTACT

s-jahangir@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: If a research MRI is combined with a clinically ordered MRI, the research scan will add about 15 minutes to the clinical MRI procedure. If a research MRI is conducted during a separate visit, it is expected that the research-only MRI visit will last about 1-2 hours. An individual may voluntarily participate in the study on multiple occasions.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: January 31, 2022
• Study Start: December 19, 2019
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 5 years

Locations

US (1)