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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814277
• Other study ID #: DOC-0055
• Status: Completed
• Start date: October 26, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: November 2023
• Source: Surgical Information Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 11, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Surgical Information Sciences	Plymouth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Surgical Information Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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