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

Completed

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

• Registration Number: NCT04814277
• Lead Sponsor: Surgical Information Sciences Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-10-26
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-11
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the accurate visualization of brain structure based on SIS algorithms - 3	Through study completion, up to 1 year	Difference in Dice Coefficient between measured brain structures
Validation of the accurate visualization of brain structure based on SIS algorithms - 2	Through study completion, up to 1 year	Difference in distance between brain structure mean surface area
Validation of the accurate visualization of brain structure based on SIS algorithms - 1	Through study completion, up to 1 year	Difference in distance between brain structure center of mass (COM)

Trial Locations

Locations (1)

Surgical Information Sciences; 🇺🇸 Plymouth, Minnesota, United States