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

Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Surgical Information Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MRI Data Collection; A group of 34 subjects will be scanned on a 3Tesla (3T) and on a 7T MRI scanner. The images will be compared.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Surgical Information Sciences Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DOC-0055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No