Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure

Surgical Information Sciences

Status: Completed

Conditions: Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images

Study type: Observational

Funder types: Industry

Identifiers

NCT04814277

DOC-0055

Details and patient eligibility

About

SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

Full description

A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images.

SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images in the same subject obtained from the 7T MRI.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.

Exclusion criteria

1. MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g,. heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.
2. Pregnant women.
3. Subject under the age of 18.

Trial design

34 participants in 1 patient group

MRI Data Collection

Description:

A group of 34 subjects will be scanned on a 3Tesla (3T) and on a 7T MRI scanner. The images will be compared.