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NCT05235646 Clinical Trial

Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

Magnetic Resonance Imaging Clinical Trial

Official title:
Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05235646
Other study ID # 21-010301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 14, 2022
Est. completion date April 5, 2022

Study information
Verified date April 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 5, 2022
Est. primary completion date April 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of Infiltration of Gadolinium contrast agent into tissue and muscle using artificial intelligence model 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
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