Trial Outcomes & Findings for MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants (NCT NCT04292301)

NCT ID: NCT04292301

Last Updated: 2022-06-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

Baseline Only

Results posted on

2022-06-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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. 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 Study
STARTED
92
Overall Study
COMPLETED
89
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
STrategically Acquired Gradient Echo (STAGE)
n=92 Participants
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
<=18 years
1 Participants
n=92 Participants
Age, Categorical
Between 18 and 65 years
89 Participants
n=92 Participants
Age, Categorical
>=65 years
2 Participants
n=92 Participants
Age, Continuous
33.4 years
STANDARD_DEVIATION 12.2 • n=92 Participants
Sex: Female, Male
Female
53 Participants
n=92 Participants
Sex: Female, Male
Male
39 Participants
n=92 Participants
Region of Enrollment
United States
92 participants
n=92 Participants

PRIMARY outcome

Timeframe: Baseline Only

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

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.

Outcome measures

Outcome measures
Measure
STrategically Acquired Gradient Echo (STAGE)
n=89 Participants
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.
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE DIR Score<=2
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Score=4
37 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Score=3
3 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Coronal Score=5
38 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Coronal Score=4
28 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Coronal Score=3
23 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Coronal Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Sagittal Score=5
44 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Sagittal Score=4
24 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Sagittal Score=3
21 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Sagittal Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1 MAP Score=5
48 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1 MAP Score=4
40 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1 MAP Score=3
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1 MAP Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PD MAP Score=5
48 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PD MAP Score=4
39 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PD MAP Score=3
2 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PD MAP Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE SWI Score=5
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE SWI Score=4
54 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE SWI Score=3
34 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE SWI Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE tSWI Score=5
3 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE tSWI Score=4
55 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE tSWI Score=3
31 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE tSWI Score=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE iSWIM Score=5
9 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE iSWIM Score=4
58 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE iSWIM Score=3
21 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE iSWIM Score<=2
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE R2* MAP Score=5
26 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE R2* MAP Score=4
35 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE R2* MAP Score=3
27 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE R2* MAP Score<=2
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T2* MAP Score=5
2 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T2* MAP Score=4
35 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T2* MAP Score=3
51 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T2* MAP Score<=2
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE MRA Score=5
35 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE MRA Score=4
27 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE MRA Score=3
27 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE MRA Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE pSWIM Score=5
34 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE pSWIM Score=4
33 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE pSWIM Score=3
22 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE pSWIM Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE mpSWIM Score=5
36 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE mpSWIM Score=4
31 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE mpSWIM Score=3
22 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE mpSWIM Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE DIR Score=5
45 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE DIR Score=4
21 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE DIR Score=3
22 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional T1W Input Score=5
49 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional T1W Input Score=4
40 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional T1W Input Score=3
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional T1W Input Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional PDW Input Score=5
44 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional PDW Input Score=4
45 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional PDW Input Score=3
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional PDW Input Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional MPRAGE Score=5
49 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional MPRAGE Score=4
40 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional MPRAGE Score=3
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
Conventional MPRAGE Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1W Score=5
49 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1W Score=4
39 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1W Score=3
1 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1W Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PDW Score=5
36 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PDW Score=4
50 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PDW Score=3
3 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE PDW Score<=2
0 Participants
Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs
STAGE T1We Score=5
49 Participants

PRIMARY outcome

Timeframe: Baseline Only

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

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.

Outcome measures

Outcome measures
Measure
STrategically Acquired Gradient Echo (STAGE)
n=89 Image Series
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.
Review of STAGE Outputs for Artifact and Image Contrast
Conventional T1MPRAGE
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
Conventional T1W
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
Conventional PDW
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE T1W
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE PDW
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE T1WE
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE T1MAP
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE PDMAP
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE SWI
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE tSWI
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE iSWIM
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE R2*MAP
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE T2*MAP
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE MRA
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE pSWIM
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE mpSWIM
0 Artifact Count
Review of STAGE Outputs for Artifact and Image Contrast
STAGE DIR
0 Artifact Count

PRIMARY outcome

Timeframe: Baseline Only

Population: 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.

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.

Outcome measures

Outcome measures
Measure
STrategically Acquired Gradient Echo (STAGE)
n=89 Image Series
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.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE SWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE SWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE tSWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE tSWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE iSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE iSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE R2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE R2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE MRA Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE MRA Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE pSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE pSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE mpSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE mpSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional T1MPRAGE Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional T1MPRAGE Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · Conventional T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1WE Criteria Met
NA Image Series
T1WE can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1WE Criteria Not Met
NA Image Series
T1WE can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1MAP Criteria Met
NA Image Series
T1MAP can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE T1MAP Criteria Not Met
NA Image Series
T1MAP can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE PDMAP Criteria Met
NA Image Series
PDMAP can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE PDMAP Criteria Not Met
NA Image Series
PDMAP can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE DIR Criteria Met
NA Image Series
DIR can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Artery and Vein · STAGE DIR Criteria Not Met
NA Image Series
DIR can not be properly assessed for Artery/Vein appearance due to the lack of signal in Artery/Vein in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional T1MPRAGE Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional T1MPRAGE Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · Conventional PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE SWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE SWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE tSWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE tSWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE iSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE iSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE R2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE R2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE MRA Criteria Met
NA Image Series
MRA can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE MRA Criteria Not Met
NA Image Series
MRA can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE pSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE pSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE mpSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE mpSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1WE Criteria Met
NA Image Series
T1WE can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1WE Criteria Not Met
NA Image Series
T1WE can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1MAP Criteria Met
NA Image Series
T1MAP can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE T1MAP Criteria Not Met
NA Image Series
T1MAP can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE PDMAP Criteria Met
NA Image Series
PDMAP can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE PDMAP Criteria Not Met
NA Image Series
PDMAP can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE DIR Criteria Met
NA Image Series
DIR can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Calcium and Iron · STAGE DIR Criteria Not Met
NA Image Series
DIR can not be properly assessed for Calcium/Iron appearance due to the lack of signal from Calcium/Iron in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional T1MPRAGE Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional T1MPRAGE Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · Conventional PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1W Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1W Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE PDW Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE PDW Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE SWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE SWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE tSWI Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE tSWI Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE iSWIM Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE iSWIM Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE R2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE R2*MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T2*MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE MRA Criteria Met
NA Image Series
MRA can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE MRA Criteria Not Met
NA Image Series
MRA can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE pSWIM Criteria Met
NA Image Series
pSWIM can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE pSWIM Criteria Not Met
NA Image Series
pSWIM can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE mpSWIM Criteria Met
NA Image Series
mpSWIM can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE mpSWIM Criteria Not Met
NA Image Series
mpSWIM can not be properly assessed for GM/WM/CSF appearance due to the lack of signal from GM/WM/CSF contrast in the image series.
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1WE Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1WE Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1MAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE T1MAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE PDMAP Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE PDMAP Criteria Not Met
0 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE DIR Criteria Met
89 Image Series
Review of STAGE Outputs for Expected Brain Structural Appearance
Gray Matter / White Matter / Cerebrospinal Fluid · STAGE DIR Criteria Not Met
0 Image Series

PRIMARY outcome

Timeframe: Baseline Only

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

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.

Outcome measures

Outcome measures
Measure
STrategically Acquired Gradient Echo (STAGE)
n=89 Participants
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.
Evaluation of STAGE Image Processing Times
3T GE Signa Premier
17.4 Time (minutes)
Standard Deviation 3.2
Evaluation of STAGE Image Processing Times
1.5T Siemens Aera
7.6 Time (minutes)
Standard Deviation 0.8
Evaluation of STAGE Image Processing Times
3T Siemens Skyra
10.1 Time (minutes)
Standard Deviation 1.7
Evaluation of STAGE Image Processing Times
3T Siemens Prisma
11.3 Time (minutes)
Standard Deviation 2.0

Adverse Events

STrategically Acquired Gradient Echo (STAGE)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rana El Hachem

SpinTech MRI

Phone: 2487126789

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place