Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures
September 12, 2016 updated by: Surgical Information Sciences Inc.
Accuracy Evaluation for Software-based Visualization of Anatomical Brain Structures 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
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.
Study Type
Observational
Enrollment (Actual)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A cohort of 30 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
MRI data collection
A group of 30 subjects will be scanned on a 3 Tesla (T) and on a 7T MRI scanners.
The images will be compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Validation of the accurate visualization of brain structures based on SIS algorithms
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
September 12, 2016
First Submitted That Met QC Criteria
September 12, 2016
First Posted (Estimate)
September 15, 2016
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- SurgicalIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images
-
Surgical Information Sciences Inc.CompletedSoftware Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR ImagesUnited States