Investigational MRI Clinical Software and Hardware

Study Overview
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Brief Summary
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Patients and healthy volunteers will be scanned in order to test new sequences.

Detailed Description
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The aims of this study are to: 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. 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.

Official Title
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Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software

Conditions
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Image, Body

Intervention / Treatment
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* Radiation: MRI
* Drug: Gadavist 2Ml Solution for Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient w/ Contrast<br>Patients will add 15 minutes to their SOC MRI for research purposes | Radiation: MRI<br>* 1.5T or 3T MRI scanner (Siemens Medical Systems)<br>Drug: Gadavist 2Ml Solution for Injection<br>* Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)<br>|
| Other: Patient no contrast<br>Patients will add 15 minutes to their SOC MRI for research purposes | Radiation: MRI<br>* 1.5T or 3T MRI scanner (Siemens Medical Systems)<br>|
| Other: Volunteer w/ contrast<br>Volunteers undergo 1 research MRI for research purposes | Radiation: MRI<br>* 1.5T or 3T MRI scanner (Siemens Medical Systems)<br>Drug: Gadavist 2Ml Solution for Injection<br>* Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)<br>|
| Other: Volunteer no contrast<br>Volunteers undergo 1 research MRI for research purposes | Radiation: MRI<br>* 1.5T or 3T MRI scanner (Siemens Medical Systems)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI hardware testing