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

NCT04292301 | Completed Results FDA Device

• 1 other identifier: CP-STAGE-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

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.

Conditions

MRI

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

STrategically Acquired Gradient Echo (STAGE)

EXPERIMENTAL

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

Device: STrategically Acquired Gradient Echo (STAGE)

Interventions

STrategically Acquired Gradient Echo (STAGE) DEVICE

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.

STrategically Acquired Gradient Echo (STAGE)

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 6-80 years of age, inclusive.
• Literate in English
• No contraindications to MR
• Not claustrophobic

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Insight Imaging - Center for Diagnostic Imaging

Los Gatos, California, 95032, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Summit Medical Center

Edmond, Oklahoma, 73013, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (3)

• 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.

  PMID: 31629075 BACKGROUND

• 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.

  PMID: 29061370 BACKGROUND

• 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.

  PMID: 29056394 BACKGROUND

Results Point of Contact

• Title: Rana El Hachem
• Organization: SpinTech MRI

rana@spintechmri.com

2487126789

Study Officials

• Douglas P Beall, MD

  Summit Medical Center

  PRINCIPAL INVESTIGATOR

• Murray A Solomon, MD

  Center for Diagnostic Imaging

  PRINCIPAL INVESTIGATOR

• Vincent Magnotta, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Karen Tong, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

• Frank Yu, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Letterio Politi, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Study does not involve masking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All human participants in the study will be imaged using MRI under the same acquisition protocol. The STAGE protocol is collected alongside conventional MR.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 3, 2020
• Study Start: June 30, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)