Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures
Completed
- Conditions
- Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images
- Registration Number
- NCT02902328
- 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 30 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (T) 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 of the same subject obtained from the 7T MRI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- all subject 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of the accurate visualization of brain structures based on SIS algorithms one year
- Secondary Outcome Measures
Name Time Method