Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2000 participants
INTERVENTIONAL
2019-12-19
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patient w/ Contrast
Patients will add 15 minutes to their SOC MRI for research purposes
MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Patient no contrast
Patients will add 15 minutes to their SOC MRI for research purposes
MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Volunteer w/ contrast
Volunteers undergo 1 research MRI for research purposes
MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Volunteer no contrast
Volunteers undergo 1 research MRI for research purposes
MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Interventions
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MRI
1.5T or 3T MRI scanner (Siemens Medical Systems)
Gadavist 2Ml Solution for Injection
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
90 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Ryan Avery
Associate Professor
Locations
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Northwestern University- Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Emily Powell
Role: primary
Saira Jahangir
Role: backup
Ryan Avery
Role: backup
Other Identifiers
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STU#00211312
Identifier Type: -
Identifier Source: org_study_id