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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292301
Acronym
STAGE
Enrollment
92
Registered
2020-03-03
Start date
2020-06-30
Completion date
2021-01-07
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRI

Keywords

Magnetic Resonance Imaging, Image Post-Processing, Neuro-Radiology

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.

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.

Interventions

DEVICESTrategically 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Study does not involve masking.

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsBaseline OnlyReading 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.
Review of STAGE Outputs for Artifact and Image ContrastBaseline OnlyReading 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.
Review of STAGE Outputs for Expected Brain Structural AppearanceBaseline OnlyReading 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.
Evaluation of STAGE Image Processing TimesBaseline OnlyReview 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.

Countries

United States

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.

Participants by arm

ArmCount
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.
92
Total92

Baseline characteristics

CharacteristicSTrategically Acquired Gradient Echo (STAGE)
Age, Categorical
<=18 years
1 Participants
Age, Categorical
>=65 years
2 Participants
Age, Categorical
Between 18 and 65 years
89 Participants
Age, Continuous33.4 years
STANDARD_DEVIATION 12.2
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
92 participants
Sex: Female, Male
Female
53 Participants
Sex: Female, Male
Male
39 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 92
other
Total, other adverse events
0 / 92
serious
Total, serious adverse events
0 / 92

Outcome results

Primary

Evaluation of STAGE Image Processing Times

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

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

ArmMeasureGroupValue (MEAN)Dispersion
STrategically Acquired Gradient Echo (STAGE)Evaluation of STAGE Image Processing Times3T GE Signa Premier17.4 Time (minutes)Standard Deviation 3.2
STrategically Acquired Gradient Echo (STAGE)Evaluation of STAGE Image Processing Times1.5T Siemens Aera7.6 Time (minutes)Standard Deviation 0.8
STrategically Acquired Gradient Echo (STAGE)Evaluation of STAGE Image Processing Times3T Siemens Skyra10.1 Time (minutes)Standard Deviation 1.7
STrategically Acquired Gradient Echo (STAGE)Evaluation of STAGE Image Processing Times3T Siemens Prisma11.3 Time (minutes)Standard Deviation 2
Primary

Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs

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

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional T1W Input Score=549 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional T1W Input Score=440 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional T1W Input Score=30 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional T1W Input Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional PDW Input Score=544 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional PDW Input Score=445 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional PDW Input Score=30 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional PDW Input Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional MPRAGE Score=549 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional MPRAGE Score=440 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional MPRAGE Score=30 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsConventional MPRAGE Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1W Score=549 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1W Score=439 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1W Score=31 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1W Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PDW Score=536 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PDW Score=450 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PDW Score=33 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PDW Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Score=549 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Score=437 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Score=33 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Coronal Score=538 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Coronal Score=428 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Coronal Score=323 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Coronal Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Sagittal Score=544 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Sagittal Score=424 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Sagittal Score=321 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1We Sagittal Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1 MAP Score=548 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1 MAP Score=440 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1 MAP Score=31 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T1 MAP Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PD MAP Score=548 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PD MAP Score=439 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PD MAP Score=32 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE PD MAP Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE SWI Score=51 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE SWI Score=454 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE SWI Score=334 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE SWI Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE tSWI Score=53 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE tSWI Score=455 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE tSWI Score=331 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE tSWI Score=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE iSWIM Score=59 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE iSWIM Score=458 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE iSWIM Score=321 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE iSWIM Score<=21 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE R2* MAP Score=526 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE R2* MAP Score=435 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE R2* MAP Score=327 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE R2* MAP Score<=21 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T2* MAP Score=52 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T2* MAP Score=435 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T2* MAP Score=351 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE T2* MAP Score<=21 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE MRA Score=535 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE MRA Score=427 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE MRA Score=327 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE MRA Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE pSWIM Score=534 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE pSWIM Score=433 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE pSWIM Score=322 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE pSWIM Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE mpSWIM Score=536 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE mpSWIM Score=431 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE mpSWIM Score=322 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE mpSWIM Score<=20 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE DIR Score=545 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE DIR Score=421 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE DIR Score=322 Participants
STrategically Acquired Gradient Echo (STAGE)Numeric Rating Scale of Clinical Usability Assessment of STAGE OutputsSTAGE DIR Score<=21 Participants
Primary

Review of STAGE Outputs for Artifact and Image Contrast

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

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

ArmMeasureGroupValue (NUMBER)
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastConventional T1MPRAGE0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastConventional T1W0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastConventional PDW0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE T1W0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE PDW0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE T1WE0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE T1MAP0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE PDMAP0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE SWI0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE tSWI0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE iSWIM0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE R2*MAP0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE T2*MAP0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE MRA0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE pSWIM0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE mpSWIM0 Artifact Count
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Artifact and Image ContrastSTAGE DIR0 Artifact Count
Primary

Review of STAGE Outputs for Expected Brain Structural Appearance

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

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.

ArmMeasureGroupCategoryValue (COUNT_OF_UNITS)
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional T1MPRAGE Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional T1MPRAGE Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinConventional PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE SWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE SWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE tSWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE tSWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE iSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE iSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE R2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE R2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE MRA Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE MRA Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE pSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE pSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE mpSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE mpSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1WE Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1WE Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1MAP Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE T1MAP Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE PDMAP Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE PDMAP Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE DIR Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceArtery and VeinSTAGE DIR Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional T1MPRAGE Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional T1MPRAGE Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronConventional PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE SWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE SWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE tSWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE tSWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE iSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE iSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE R2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE R2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE MRA Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE MRA Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE pSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE pSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE mpSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE mpSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1WE Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1WE Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1MAP Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE T1MAP Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE PDMAP Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE PDMAP Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE DIR Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceCalcium and IronSTAGE DIR Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional T1MPRAGE Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional T1MPRAGE Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidConventional PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1W Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1W Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE PDW Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE PDW Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE SWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE SWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE tSWI Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE tSWI Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE iSWIM Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE iSWIM Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE R2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE R2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T2*MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T2*MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE MRA Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE MRA Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE pSWIM Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE pSWIM Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE mpSWIM Criteria MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE mpSWIM Criteria Not MetNA Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1WE Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1WE Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1MAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE T1MAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE PDMAP Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE PDMAP Criteria Not Met0 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE DIR Criteria Met89 Image Series
STrategically Acquired Gradient Echo (STAGE)Review of STAGE Outputs for Expected Brain Structural AppearanceGray Matter / White Matter / Cerebrospinal FluidSTAGE DIR Criteria Not Met0 Image Series

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026