Surgical Information Sciences
Plymouth, Minnesota, 55441, United States
Completed
NCT Number: NCT04814277
Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure
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.
Completed
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Notify MeKey information
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
- 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.
- Pregnant women.
- Subject under the age of 18.
Treatment and study plan
Primary outcomes
-
Validation of the accurate visualization of brain structure based on SIS algorithms - 1
Time frame: Through study completion, up to 1 year
Difference in distance between brain structure center of mass (COM)
-
Validation of the accurate visualization of brain structure based on SIS algorithms - 2
Time frame: 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 - 3
Time frame: Through study completion, up to 1 year
Difference in Dice Coefficient between measured brain structures
Sponsors and collaborators
Lead sponsor
Surgical Information Sciences Inc.
Industry
Registry information
Official study title
Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Mar 24, 2021
- Registry last updated
- Nov 22, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.