MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants
Condition: MRI
Study type: Interventional

Summary: 
      The study's purpose is to validate STAGE images and, when applicable, their equivalence to
      conventional MRI through an assessment by a trained certified neuroradiologist in a clinical
      setting. For STAGE images without conventional equivalent, the neuroradiologist will
      determine if their contrasts, intensities, and quality are sufficient and meet expectations
      for images used in radiological reads of the brain. The study is a multi-center study in
      which STAGE can be assessed at sites with different MRI manufacturers and field strengths.
      Site names will be made available to the collaborators and participants. The sponsor is based
      out of Michigan, while participating sites may be located in other states. Any funding for
      the study will come from an industry source, SpinTech, Inc.
    

Detailed description: 
      The scope of the study includes the acquisition of MR images from a specified MR
      manufacturer, the installation of the STAGE device at the clinical site, the subsequent
      processing of the acquired MR images, and their evaluation by neuroradiologists. The follow
      section will summarize the key procedures which are involved in this study.

        1. Participants will be enrolled as study subjects per IRB approved protocol and informed
           consent.

        2. The STAGE device will be installed at the clinical site. The installation of the
           Investigational STAGE module requires it to be labeled for Investigational Use Only, per
           FDA requirements. It requires an available power source and live Ethernet connection.
           STAGE is connected to the PACS via a node which requires the AE title and an assigned IP
           address. The node will only accept images which meet the STAGE protocol requirements and
           any other images are not used. After the images are processed and sent back to the PACS
           system, all data are purged from the STAGE module. A log is kept of which data was
           processed which can be viewed through the assigned IP within a web browser. All images
           under the study protocol shall be labeled "For Investigational Device Use Only".

        3. The PI and Co-Investigators will be trained on the use of installed STAGE
           investigational device. This will include a review of the installation and user manuals
           written as documentation under the FDA regulated development process. Documentation of
           the training process will be documented with data workflow and output images being
           presented.

        4. After these steps the clinical study collection of MR images will begin. Since a primary
           aim of STAGE is to reduce acquisition times while generating a wealth of contrasts from
           the dataset, additional conventional MR images will be acquired including but not
           limited to: T1W, Susceptibility Weighted Images (SWI), Magnetic Resonance Angiography
           (MRA), and Spin Density Weighted (PDW). The patient's time in the magnet will be kept
           under 40 minutes. The STAGE protocol is available for Siemens, GE, Philips, and
           Canon/Toshiba magnets at both 1.5T and 3.0T field strengths. The processed STAGE images
           will be sent back to the PACS system where they remain within the participant's scan
           folder and are clearly labeled. They can then be viewed at an integrated workstation.

        5. The study data will then be collected on Case Report Forms to record the response from
           the reading radiologist as well as the documented acquisition times for the STAGE
           protocol and the standard of care acquisition times used within that clinical setting
           (control arm of study). Prospective data will include imaging as well as
           questionnaire/survey with the radiologist to evaluate the performance of STAGE and its
           outputs. The study will not consist of retrospective data.

        6. Clinical study completions and closeout. At the conclusion of the study, STAGE will be
           removed from the site by a trained technician and all data from the study will be purged
           from the PACS. A checklist will be documented to show that all measurable clinical
           response metrics have been recorded and that the study has successfully contributed its
           intended aims while following IRB and FDA regulations for clinical studies.
    

Intervention name(s): STrategically Acquired Gradient Echo (STAGE)
Intervention type(s): Device
Intervention description(s): The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired.
Intervention model: Single Group Assignment
Intervention model description: All human participants in the study will be imaged using MRI under the same acquisition protocol. The STAGE protocol is collected alongside conventional MR.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Magnetic Resonance Imaging; Image Post-Processing; Neuro-Radiology