Avery HS: Investigational MRI Clinical Software and Hardware

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05215132
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 61.4
• Patients Per Site Per Month: 32.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Image, Body	Radiation: MRI; Drug: Gadavist 2Ml Solution for Injection	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
• Actual Study Start Date: Dec 19, 2019
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: Jan 31, 2025

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Conduct clinical protocol development and validation [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.

Secondary Outcome Measures

1. Demonstrate and train [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: 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:

• • 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University- Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ryan Avery, Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT05215132
• Other Study ID Numbers: STU#00211312
• First Posted: Jan 31, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Ryan Avery, Associate Professor, Northwestern University: MRI hardware testing

Study Results

No Results Posted as of Jul 25, 2022