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Recruiting Phase 4 NCT05215132

Investigational MRI Clinical Software and Hardware

Phase 4 – monitoring after market approval
Conditions: Image, Body

Sponsor: Northwestern University

trial.available_in: БГ
Overview
Patients and healthy volunteers will be scanned in order to test new sequences.
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.
Who can participate
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
Interventions
MRI
RADIATION
Gadavist 2Ml Solution for Injection
DRUG
Locations 1
United States (1)
Northwestern University- Feinberg School of Medicine
Chicago , Illinois
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
19.12.2019
Completion date
31.01.2028
Registry ID
NCT05215132
Source
clinicaltrials.gov
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