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

MRI Clinical Trial

— STAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292301
• Other study ID #: CP-STAGE-001
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: May 2022
• Source: SpinTech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• MRI

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Summit Medical Center	Edmond	Oklahoma
United States	University of Iowa	Iowa City	Iowa
United States	Loma Linda University Health	Loma Linda	California
United States	Insight Imaging - Center for Diagnostic Imaging	Los Gatos	California

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline Only
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.	Baseline Only
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.	Baseline Only
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.	Baseline Only