- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235646
Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
April 8, 2022 updated by: James G. Pipe, Mayo Clinic
Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
The purpose of this research is to develop machine learning algorithms to analyze images from brain MRI to confirm that contrast agent has been correctly administered.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults undergoing MR brain without and with IV contrast examination as part of their care plan.
Description
Inclusion Criteria:
- Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.
Exclusion Criteria:
- None
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of Infiltration of Gadolinium contrast agent into tissue and muscle using artificial intelligence model
Time Frame: 2 months
|
Correct detection of the presence of infiltration of Gadolinium contrast agent into tissue and muscleusing an artificial intelligence model.
This outcome will be determined by measuring the difference in signal enhancement in the nasal mucosa or the lack of signal enhancement within the nasal mucosa.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Pipe, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (ACTUAL)
March 14, 2022
Primary Completion (ACTUAL)
April 5, 2022
Study Completion (ACTUAL)
April 5, 2022
Study Registration Dates
First Submitted
January 19, 2022
First Submitted That Met QC Criteria
February 8, 2022
First Posted (ACTUAL)
February 11, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 11, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 21-010301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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