Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR ImagesNCT04814277
Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure
An observational study of Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images, run by Surgical Information Sciences Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 11 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.
Who may be able to join
- All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Surgical Information Sciences
Plymouth, Minnesota, 55441
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Validation of the accurate visualization of brain structure based on SIS algorithms - 1
Difference in distance between brain structure center of mass (COM)
Measured: 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
Measured: 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
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start26 Oct 2020
- Primary completion5 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR ImagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgical Information Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814277
- Sponsor's protocol ID
- DOC-0055
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms
- ClinicalTrials.gov ID
- NCT04814277
- Acronym / sponsor ID
- DOC-0055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Surgical Information Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.
Key inclusion criteria (1 listed)
- All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images, run by Surgical Information Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the accurate visualization of brain structure based on SIS algorithms - 1 (time frame: Through study completion, up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.