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

• Sponsor: SpinTech, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04292301
• Collaborator: Summit Medical Center (Other), Center for Diagnostic Imaging (Other), Loma Linda University (Other), University of Texas Southwestern Medical Center (Other), University of Iowa (Other), University of Massachusetts, Worcester (Other)
• Enrollment: 92
• Locations: 5
• Arm: 1
• Actual Duration (Months): 6.3
• Patients Per Site: 18.4
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
MRI	Device: STrategically Acquired Gradient Echo (STAGE)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: N/A
• 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.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)
• Masking Description: Study does not involve masking.
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Jun 30, 2020
• Actual Primary Completion Date: Jan 7, 2021
• Actual Study Completion Date: Jan 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STrategically Acquired Gradient Echo (STAGE) 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs [Baseline Only]

   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.

2. Review of STAGE Outputs for Artifact and Image Contrast [Baseline Only]

   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.

3. Review of STAGE Outputs for Expected Brain Structural Appearance [Baseline Only]

   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.

4. Evaluation of STAGE Image Processing Times [Baseline Only]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects 6-80 years of age, inclusive.

• Literate in English

• No contraindications to MR

• Not claustrophobic

Exclusion Criteria:

• Subject has diffuse white matter disease or leukoaraiosis.

• Participant, or if participant is under 18 years of age, participant's parent or guardian unable to read and sign an informed consent.

• Women who are pregnant or breast-feeding.

• Those with major surgery within the past eight weeks or scheduled surgery within 30 days.

• Chronic back pain or inability to lie still for 5 minutes or more.

• History of drug or alcohol abuse.

• Individuals who exceed 28 BMI or 320 lbs.

• Individual whose girth exceeds the magnetic bore.

• Direct employee or student of the PI.

• Participants belong to a vulnerable group.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Health	Loma Linda	California	United States	92354
2	Insight Imaging - Center for Diagnostic Imaging	Los Gatos	California	United States	95032
3	University of Iowa	Iowa City	Iowa	United States	52242
4	Summit Medical Center	Edmond	Oklahoma	United States	73013
5	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• SpinTech, Inc.
• Summit Medical Center
• Center for Diagnostic Imaging
• Loma Linda University
• University of Texas Southwestern Medical Center
• University of Iowa
• University of Massachusetts, Worcester

Investigators

• Principal Investigator: Douglas P Beall, MD, Summit Medical Center
• Principal Investigator: Murray A Solomon, MD, Center for Diagnostic Imaging
• Principal Investigator: Vincent Magnotta, MD, University of Iowa
• Principal Investigator: Karen Tong, MD, Loma Linda University Health
• Principal Investigator: Frank Yu, MD, University of Texas
• Principal Investigator: Letterio Politi, MD, University of Massachusetts, Worcester

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 10, 2020
• Informed Consent Form - Jan 13, 2020

More Information

Publications

• Chen Y, Liu S, Wang Y, Kang Y, Haacke EM. STrategically Acquired Gradient Echo (STAGE) imaging, part I: Creating enhanced T1 contrast and standardized susceptibility weighted imaging and quantitative susceptibility mapping. Magn Reson Imaging. 2018 Feb;46:130-139. doi: 10.1016/j.mri.2017.10.005. Epub 2017 Oct 19.
• Haacke EM, Chen Y, Utriainen D, Wu B, Wang Y, Xia S, He N, Zhang C, Wang X, Lagana MM, Luo Y, Fatemi A, Liu S, Gharabaghi S, Wu D, Sethi SK, Huang F, Sun T, Qu F, Yadav BK, Ma X, Bai Y, Wang M, Cheng J, Yan F. STrategically Acquired Gradient Echo (STAGE) imaging, part III: Technical advances and clinical applications of a rapid multi-contrast multi-parametric brain imaging method. Magn Reson Imaging. 2020 Jan;65:15-26. doi: 10.1016/j.mri.2019.09.006. Epub 2019 Oct 16.
• Wang Y, Chen Y, Wu D, Wang Y, Sethi SK, Yang G, Xie H, Xia S, Haacke EM. STrategically Acquired Gradient Echo (STAGE) imaging, part II: Correcting for RF inhomogeneities in estimating T1 and proton density. Magn Reson Imaging. 2018 Feb;46:140-150. doi: 10.1016/j.mri.2017.10.006. Epub 2017 Oct 20.

• Responsible Party: SpinTech, Inc.
• ClinicalTrials.gov Identifier: NCT04292301
• Other Study ID Numbers: CP-STAGE-001
• First Posted: Mar 3, 2020
• Last Update Posted: Jun 28, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by SpinTech, Inc.: Magnetic Resonance Imaging; Image Post-Processing; Neuro-Radiology

Study Results

Participant Flow

Recruitment Details	Subject recruitment took place across three sites and resulted in a total of 92 participant enrollment with 89 participants remaining after attrition. Recruitment took place between July 2020 and December 2020.

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	92
COMPLETED	89
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Overall Participants	92
Age (Count of Participants)
<=18 years	1 1.1%
Between 18 and 65 years	89 96.7%
>=65 years	2 2.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.4 (12.2)
Sex: Female, Male (Count of Participants)
Female	53 57.6%
Male	39 42.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	92 100%

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Description	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.
Time Frame	Baseline Only

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Measure Participants	89
Conventional T1W Input Score=5	49 53.3%
Conventional T1W Input Score=4	40 43.5%
Conventional T1W Input Score=3	0 0%
Conventional T1W Input Score<=2	0 0%
Conventional PDW Input Score=5	44 47.8%
Conventional PDW Input Score=4	45 48.9%
Conventional PDW Input Score=3	0 0%
Conventional PDW Input Score<=2	0 0%
Conventional MPRAGE Score=5	49 53.3%
Conventional MPRAGE Score=4	40 43.5%
Conventional MPRAGE Score=3	0 0%
Conventional MPRAGE Score<=2	0 0%
STAGE T1W Score=5	49 53.3%
STAGE T1W Score=4	39 42.4%
STAGE T1W Score=3	1 1.1%
STAGE T1W Score<=2	0 0%
STAGE PDW Score=5	36 39.1%
STAGE PDW Score=4	50 54.3%
STAGE PDW Score=3	3 3.3%
STAGE PDW Score<=2	0 0%
STAGE T1We Score=5	49 53.3%
STAGE T1We Score=4	37 40.2%
STAGE T1We Score=3	3 3.3%
STAGE T1We Score<=2	0 0%
STAGE T1We Coronal Score=5	38 41.3%
STAGE T1We Coronal Score=4	28 30.4%
STAGE T1We Coronal Score=3	23 25%
STAGE T1We Coronal Score<=2	0 0%
STAGE T1We Sagittal Score=5	44 47.8%
STAGE T1We Sagittal Score=4	24 26.1%
STAGE T1We Sagittal Score=3	21 22.8%
STAGE T1We Sagittal Score<=2	0 0%
STAGE T1 MAP Score=5	48 52.2%
STAGE T1 MAP Score=4	40 43.5%
STAGE T1 MAP Score=3	1 1.1%
STAGE T1 MAP Score<=2	0 0%
STAGE PD MAP Score=5	48 52.2%
STAGE PD MAP Score=4	39 42.4%
STAGE PD MAP Score=3	2 2.2%
STAGE PD MAP Score<=2	0 0%
STAGE SWI Score=5	1 1.1%
STAGE SWI Score=4	54 58.7%
STAGE SWI Score=3	34 37%
STAGE SWI Score<=2	0 0%
STAGE tSWI Score=5	3 3.3%
STAGE tSWI Score=4	55 59.8%
STAGE tSWI Score=3	31 33.7%
STAGE tSWI Score=2	0 0%
STAGE iSWIM Score=5	9 9.8%
STAGE iSWIM Score=4	58 63%
STAGE iSWIM Score=3	21 22.8%
STAGE iSWIM Score<=2	1 1.1%
STAGE R2* MAP Score=5	26 28.3%
STAGE R2* MAP Score=4	35 38%
STAGE R2* MAP Score=3	27 29.3%
STAGE R2* MAP Score<=2	1 1.1%
STAGE T2* MAP Score=5	2 2.2%
STAGE T2* MAP Score=4	35 38%
STAGE T2* MAP Score=3	51 55.4%
STAGE T2* MAP Score<=2	1 1.1%
STAGE MRA Score=5	35 38%
STAGE MRA Score=4	27 29.3%
STAGE MRA Score=3	27 29.3%
STAGE MRA Score<=2	0 0%
STAGE pSWIM Score=5	34 37%
STAGE pSWIM Score=4	33 35.9%
STAGE pSWIM Score=3	22 23.9%
STAGE pSWIM Score<=2	0 0%
STAGE mpSWIM Score=5	36 39.1%
STAGE mpSWIM Score=4	31 33.7%
STAGE mpSWIM Score=3	22 23.9%
STAGE mpSWIM Score<=2	0 0%
STAGE DIR Score=5	45 48.9%
STAGE DIR Score=4	21 22.8%
STAGE DIR Score=3	22 23.9%
STAGE DIR Score<=2	1 1.1%

2. Primary Outcome

Title	Review of STAGE Outputs for Artifact and Image Contrast
Description	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.
Time Frame	Baseline Only

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Measure Participants	89
Measure Image Series	89
Conventional T1MPRAGE	0
Conventional T1W	0
Conventional PDW	0
STAGE T1W	0
STAGE PDW	0
STAGE T1WE	0
STAGE T1MAP	0
STAGE PDMAP	0
STAGE SWI	0
STAGE tSWI	0
STAGE iSWIM	0
STAGE R2*MAP	0
STAGE T2*MAP	0
STAGE MRA	0
STAGE pSWIM	0
STAGE mpSWIM	0
STAGE DIR	0

3. Primary Outcome

Title	Review of STAGE Outputs for Expected Brain Structural Appearance
Description	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.
Time Frame	Baseline Only

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Measure Participants	89
Measure Image Series	89
Conventional T1MPRAGE Criteria Met	89
Conventional T1MPRAGE Criteria Not Met	0
Conventional T1W Criteria Met	89
Conventional T1W Criteria Not Met	0
Conventional PDW Criteria Met	89
Conventional PDW Criteria Not Met	0
STAGE T1W Criteria Met	89
STAGE T1W Criteria Not Met	0
STAGE PDW Criteria Met	89
STAGE PDW Criteria Not Met	0
STAGE SWI Criteria Met	89
STAGE SWI Criteria Not Met	0
STAGE tSWI Criteria Met	89
STAGE tSWI Criteria Not Met	0
STAGE iSWIM Criteria Met	89
STAGE iSWIM Criteria Not Met	0
STAGE R2*MAP Criteria Met	89
STAGE R2*MAP Criteria Not Met	0
STAGE T2*MAP Criteria Met	89
STAGE T2*MAP Criteria Not Met	0
STAGE MRA Criteria Met	89
STAGE MRA Criteria Not Met	0
STAGE pSWIM Criteria Met	89
STAGE pSWIM Criteria Not Met	0
STAGE mpSWIM Criteria Met	89
STAGE mpSWIM Criteria Not Met	0
STAGE T1WE Criteria Met	NA
STAGE T1WE Criteria Not Met	NA
STAGE T1MAP Criteria Met	NA
STAGE T1MAP Criteria Not Met	NA
STAGE PDMAP Criteria Met	NA
STAGE PDMAP Criteria Not Met	NA
STAGE DIR Criteria Met	NA
STAGE DIR Criteria Not Met	NA
Conventional T1MPRAGE Criteria Met	89
Conventional T1MPRAGE Criteria Not Met	0
Conventional T1W Criteria Met	89
Conventional T1W Criteria Not Met	0
Conventional PDW Criteria Met	89
Conventional PDW Criteria Not Met	0
STAGE T1W Criteria Met	89
STAGE T1W Criteria Not Met	0
STAGE PDW Criteria Met	89
STAGE PDW Criteria Not Met	0
STAGE SWI Criteria Met	89
STAGE SWI Criteria Not Met	0
STAGE tSWI Criteria Met	89
STAGE tSWI Criteria Not Met	0
STAGE iSWIM Criteria Met	89
STAGE iSWIM Criteria Not Met	0
STAGE R2*MAP Criteria Met	89
STAGE R2*MAP Criteria Not Met	0
STAGE T2*MAP Criteria Met	89
STAGE T2*MAP Criteria Not Met	0
STAGE MRA Criteria Met	NA
STAGE MRA Criteria Not Met	NA
STAGE pSWIM Criteria Met	89
STAGE pSWIM Criteria Not Met	0
STAGE mpSWIM Criteria Met	89
STAGE mpSWIM Criteria Not Met	0
STAGE T1WE Criteria Met	NA
STAGE T1WE Criteria Not Met	NA
STAGE T1MAP Criteria Met	NA
STAGE T1MAP Criteria Not Met	NA
STAGE PDMAP Criteria Met	NA
STAGE PDMAP Criteria Not Met	NA
STAGE DIR Criteria Met	NA
STAGE DIR Criteria Not Met	NA
Conventional T1MPRAGE Criteria Met	89
Conventional T1MPRAGE Criteria Not Met	0
Conventional T1W Criteria Met	89
Conventional T1W Criteria Not Met	0
Conventional PDW Criteria Met	89
Conventional PDW Criteria Not Met	0
STAGE T1W Criteria Met	89
STAGE T1W Criteria Not Met	0
STAGE PDW Criteria Met	89
STAGE PDW Criteria Not Met	0
STAGE SWI Criteria Met	89
STAGE SWI Criteria Not Met	0
STAGE tSWI Criteria Met	89
STAGE tSWI Criteria Not Met	0
STAGE iSWIM Criteria Met	89
STAGE iSWIM Criteria Not Met	0
STAGE R2*MAP Criteria Met	89
STAGE R2*MAP Criteria Not Met	0
STAGE T2*MAP Criteria Met	89
STAGE T2*MAP Criteria Not Met	0
STAGE MRA Criteria Met	NA
STAGE MRA Criteria Not Met	NA
STAGE pSWIM Criteria Met	NA
STAGE pSWIM Criteria Not Met	NA
STAGE mpSWIM Criteria Met	NA
STAGE mpSWIM Criteria Not Met	NA
STAGE T1WE Criteria Met	89
STAGE T1WE Criteria Not Met	0
STAGE T1MAP Criteria Met	89
STAGE T1MAP Criteria Not Met	0
STAGE PDMAP Criteria Met	89
STAGE PDMAP Criteria Not Met	0
STAGE DIR Criteria Met	89
STAGE DIR Criteria Not Met	0

4. Primary Outcome

Title	Evaluation of STAGE Image Processing Times
Description	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.
Time Frame	Baseline Only

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
Measure Participants	89
3T GE Signa Premier	17.4 (3.2)
1.5T Siemens Aera	7.6 (0.8)
3T Siemens Skyra	10.1 (1.7)
3T Siemens Prisma	11.3 (2.0)

Adverse Events

Time Frame	Adverse event data collected per MRI routine examination, approximately up to 90 minutes. Participants were observed during the MRI scan. No follow-up data were recorded.
Arm/Group Title	STrategically Acquired Gradient Echo (STAGE)
Arm/Group Description	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.
All Cause Mortality
	STrategically Acquired Gradient Echo (STAGE)
	Affected / at Risk (%)	# Events
Total	0/92 (0%)
Serious Adverse Events
	STrategically Acquired Gradient Echo (STAGE)
	Affected / at Risk (%)	# Events
Total	0/92 (0%)
Other (Not Including Serious) Adverse Events
	STrategically Acquired Gradient Echo (STAGE)
	Affected / at Risk (%)	# Events
Total	0/92 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.