Magnetic Resonance ImagingNCT05235646
Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
An observational study of Magnetic Resonance Imaging, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 5 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing MR brain without and with IV contrast examination as part of their care plan.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Magnetic Resonance Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start14 Mar 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James G. Pipe, Mayo Clinic
- Investigators
- James Pipe, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235646
- Sponsor's protocol ID
- 21-010301
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05235646
- Acronym / sponsor ID
- 21-010301
- Conditions
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 11 Feb 2022 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing MR brain without and with IV contrast examination as part of their care plan.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
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
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.
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 11 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
James Pipe, PhD principal investigator
Mayo Clinic
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 Magnetic Resonance Imaging, run by Mayo Clinic 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 1 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 11 Apr 2022. 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?
Detection of Infiltration of Gadolinium contrast agent into tissue and muscle using artificial intelligence model (time frame: 2 months). 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 11 Apr 2022.