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

SpinTech

Status: Completed

Conditions: MRI

Treatments: Device: STrategically Acquired Gradient Echo (STAGE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04292301

CP-STAGE-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 6 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

STrategically Acquired Gradient Echo (STAGE)

Experimental group

Description:

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

Treatment:

Device: STrategically Acquired Gradient Echo (STAGE)