MedPath

Development of MRI technology for improved visualization and quantification of tissue and organs in healthy volunteers

Conditions
gezond
tissues and organs
Registration Number
NL-OMON47106
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
500
Inclusion Criteria

- Healthy subject (defined as a volunteer who is not referred to Erasmus MC with signs and symptoms of disease)
- At least 18 years old
- Signed informed consent

Exclusion Criteria

- Subjects with a typical contra-indication to an MRI exam.
- Subjects with metal implants.
- Subjects who have a documented allergy to MRI contrast media or a contra-indication for - contrast-media are eligible for MRI, but will not undergo contrast-enhanced MRI.
- Woman who are pregnant or lactating
- Having any physical or mental status that interferes with the informed consent procedure

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Generally, data will be collected and analysis techniques will be used as<br /><br>appropriate for the specific project and its purpose. The following parameters<br /><br>are likely to be collected:<br /><br>* Overall Image quality and (physiological) artifacts will be ranked on a five<br /><br>point scale.<br /><br>* SNR and CNR (lesion versus background) will be measured.<br /><br>* Calculation of quantitative parameter values (e.g. T1, T2) when relevant.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>* If applicable, the reproducibility of derived quantitative parameters will be<br /><br>asessed, and these parameters will be compared with reference values from<br /><br>literature (if available) or with reference values derived from standard<br /><br>clinical MR series.<br /><br>* If applicable, the results of (semi-)automated image post-processing<br /><br>techniques will be compared with manual annotations in terms of accuracy,<br /><br>reproducibility, and robustness.<br /><br>* If applicable, the presence of false positives or false negatives (using the<br /><br>standard clinical MR series as ground truth) will be assessed.<br /><br>* If applicable, workflow aspects will be documented and analyzed.<br /><br></p><br>
© Copyright 2025. All Rights Reserved by MedPath