Investigational MRI Clinical Software and Hardware

Phase 4RecruitingNCT05215132

Northwestern University2,000 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,000

Conditions

Image, Body

Interventions

MRIRADIATION

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

Gadavist 2Ml Solution for InjectionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University- Feinberg School of Medicine

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Emily Powell

CONTACT

312.695.2956 emily.powell@northwestern.edu

Saira Jahangir

CONTACT

s-jahangir@northwestern.edu

Data from ClinicalTrials.gov

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