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.

MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants

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.

STrategically Acquired Gradient Echo (STAGE)

Multi-Centered Study Comparison of Output Images From STrategically Acquired Gradient Echo to Conventional 1.5 T and 3.0 T Magnetic Resonance Images and Assessing Their Clinical Usability on Human Participants

Reading radiologists responses on the clinical usability of STAGE Outputs based on image quality using a numeric rating scale of 1 to 5 with: 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent. Scores of 3 or greater are considered clinically usable.

Reading radiologist and image analyst responses on the clinical usability of STAGE Outputs based on image quality using a yes/no criteria for presence of novel or accentuated imaging artifact. Hardware or participant artifact contributions (i.e. coil sensitivity and motion) were not considered unless noted as increased due to the STAGE method. Each image series was evaluated for the presence of artifact. The total count of the artifacts reported across series evaluated in the study is reported.

Reading radiologists responses on the clinical usability of STAGE Outputs based on image appearance of specified brain structures using pass/fail criteria. Expected brain contrast between tissue types will vary depending on the output reviewed (i.e. T1W, PDW, SWI). The behavior of tissue contrasts (i.e. white matter vs gray matter) should also demonstrate standard anatomic contrast (T1W, PDW, SWI) as well quantitative ratio for maps (T2*MAP, R2*MAP, SWIM, T1MAP, PDMAP). For artery/vein appearance, STAGE T1W, T1MAP and PD MAP were not evaluated due to artery/vein not appearing in the image contrasts. For GM/WM/CSF, the MRA, pSWIM and mpSWIM were not evaluated due to the anatomic contrast not appearing in the image contrasts. For calcium/iron appearance, T1WE, T1MAP, PDMAP, MRA, and DIR were not evaluated due to the calcium/iron not appearing in the image contrasts.

Review of the recorded processing times for the STAGE module to accept and process STAGE inputs and to export them back to the PACS as STAGE outputs.

STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.

Loma Linda University Health

Insight Imaging - Center for Diagnostic Imaging

University of Iowa

Summit Medical Center

University of Texas Southwestern Medical Center

STAGE Inputs are flow compensated 3D gradient echo MR images acquired at optimal parameters which are used to calculate multiple contrasts for brain imaging. All subjects within the study are imaged using both a conventional MR protocol and STAGE protocol.

STrategically Acquired Gradient Echo (STAGE): 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.

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

92 participants were imaged using STAGE and conventional MR protocols. 89 participants were included in the final analysis after an attrition of 3 participants data due to image artifact due to excessive patient motion or acquisition hardware error.

Rana El Hachem

Conventional T1W Input Score=5

Conventional T1W Input Score=4

Conventional T1W Input Score=3

Conventional T1W Input Score<=2

Conventional PDW Input Score=5

Conventional PDW Input Score=4

Conventional PDW Input Score=3

Conventional PDW Input Score<=2

Conventional MPRAGE Score=5

Conventional MPRAGE Score=4

Conventional MPRAGE Score=3

Conventional MPRAGE Score<=2

STAGE T1W Score=5

STAGE T1W Score=4

STAGE T1W Score=3

STAGE T1W Score<=2

STAGE PDW Score=5

STAGE PDW Score=4

STAGE PDW Score=3

STAGE PDW Score<=2

STAGE T1We Score=5

STAGE T1We Score=4

STAGE T1We Score=3

STAGE T1We Score<=2

STAGE T1We Coronal Score=5

STAGE T1We Coronal Score=4

STAGE T1We Coronal Score=3

STAGE T1We Coronal Score<=2

STAGE T1We Sagittal Score=5

STAGE T1We Sagittal Score=4

STAGE T1We Sagittal Score=3

STAGE T1We Sagittal Score<=2

STAGE T1 MAP Score=5

STAGE T1 MAP Score=4

STAGE T1 MAP Score=3

STAGE T1 MAP Score<=2

STAGE PD MAP Score=5

STAGE PD MAP Score=4

STAGE PD MAP Score=3

STAGE PD MAP Score<=2

STAGE SWI Score=5

STAGE SWI Score=4

STAGE SWI Score=3

STAGE SWI Score<=2

STAGE tSWI Score=5

STAGE tSWI Score=4

STAGE tSWI Score=3

STAGE tSWI Score=2

STAGE iSWIM Score=5

STAGE iSWIM Score=4

STAGE iSWIM Score=3

STAGE iSWIM Score<=2

STAGE R2* MAP Score=5

STAGE R2* MAP Score=4

STAGE R2* MAP Score=3

STAGE R2* MAP Score<=2

STAGE T2* MAP Score=5

STAGE T2* MAP Score=4

STAGE T2* MAP Score=3

STAGE T2* MAP Score<=2

STAGE MRA Score=5

STAGE MRA Score=4

STAGE MRA Score=3

STAGE MRA Score<=2

STAGE pSWIM Score=5

STAGE pSWIM Score=4

STAGE pSWIM Score=3

STAGE pSWIM Score<=2

STAGE mpSWIM Score=5

STAGE mpSWIM Score=4

STAGE mpSWIM Score=3

STAGE mpSWIM Score<=2

STAGE DIR Score=5

STAGE DIR Score=4

STAGE DIR Score=3

STAGE DIR Score<=2

Scores of 3 or greater are considered clinically acceptable. The count of participants is presented for each score and for each STAGE output series.

Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs

Conventional T1MPRAGE

Conventional T1W

Conventional PDW

STAGE T1W

STAGE PDW

STAGE T1WE

STAGE T1MAP

STAGE PDMAP

STAGE SWI

STAGE tSWI

STAGE iSWIM

STAGE R2*MAP

STAGE T2*MAP

STAGE MRA

STAGE pSWIM

STAGE mpSWIM

STAGE DIR

Reported number of observed artifacts within image series are shown as a count.

Review of STAGE Outputs for Artifact and Image Contrast

Artery and Vein

Calcium and Iron

Gray Matter / White Matter / Cerebrospinal Fluid

Reading radiologists responses on the clinical usability of STAGE Outputs based on image appearance of specified brain structures using pass/fail criteria. Expected brain contrast between tissue types will vary depending on the output reviewed (i.e. T1W, PDW, SWI). The behavior of tissue contrasts (i.e. white matter vs gray matter) should also demonstrate standard anatomic contrast (T1W, PDW, SWI) as well quantitative ratio for maps (T2\*MAP, R2\*MAP, SWIM, T1MAP, PDMAP). For artery/vein appearance, STAGE T1W, T1MAP and PD MAP were not evaluated due to artery/vein not appearing in the image contrasts. For GM/WM/CSF, the MRA, pSWIM and mpSWIM were not evaluated due to the anatomic contrast not appearing in the image contrasts. For calcium/iron appearance, T1WE, T1MAP, PDMAP, MRA, and DIR were not evaluated due to the calcium/iron not appearing in the image contrasts.

Image series were evaluated for 1) correct artery/vein appearance, 2) calcium/iron appearance, and 3) contrast between gray matter, white matter, and cerebrospinal fluid. Data were evaluated across all STAGE output images based on these structures appearance. The count of image series units is shown as either meeting criteria or not.

Review of STAGE Outputs for Expected Brain Structural Appearance

3T GE Signa Premier

1.5T Siemens Aera

3T Siemens Skyra

3T Siemens Prisma

The average and minimum/maximum processing times for STAGE were evaluated across scanners, resolutions, and field strengths.

Evaluation of STAGE Image Processing Times

Overall Study

MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?