Health TrialsbyHealthPanel

Investigational MRI Clinical Software and Hardware

ConditionImage, Body
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNorthwestern University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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

Disqualifiers

• 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI

    Radiation

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

  • Gadavist 2Ml Solution for Injection

    Drug

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

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: Patient w/ ContrastOther 2 interventions
Group B: Patient no contrastOther 1 intervention
Group C: Volunteer w/ contrastOther 2 interventions
Group D: Volunteer no contrastOther 1 intervention

Trial outcomes

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.

Time frame
5 years

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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