The use of CEUS in the assessment of uterine fibroids, a feasibility study.
Not yet recruiting
- Conditions
- fibroids, contrast enhanced sonography, ultrasound
- Registration Number
- NL-OMON26440
- Lead Sponsor
- VU medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Older than 18 years of age; Suspected uterine leiomyomas; scheduled for dynamic MRI
Exclusion Criteria
- Postmenopausal woman
– Women with an known allergy to SonoVue or any of its components
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To test the feasibility of CEUS in visualizing uterine leiomyomas and their vascularization. <br /><br>- To observe the enhancement pattern and time-intensity curve obtained from CEUS.<br>
- Secondary Outcome Measures
Name Time Method - Characterization of uterine leimyomas visualized with CEUS, and to describe their vascular pattern by making a micro-vascular imaging. <br /><br>- Calculating mean and the standard deviation for the following parameters to quantify vascularization, in order to be able to make a proper power calculation for further research:<br /><br>* For CEUS time-intensity curves will be made of the region of interest and the following parameters will be calculated: arrival time, peak-time, wash-in time, mean transit time, peak value, wash-in rate and area under the curve.<br /><br>* For dynamic MRI time-intensity curves will be made of the region of interest and the following parameters will be calculated: arrival time, peak-time, wash-in time, mean transit time, peak value, wash-in rate and area under the curve.<br /><br>* For 3D power Doppler PI, RI, FI, VI and VFI will be calculated.<br>
Related Research Topics
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What molecular mechanisms underlie CEUS imaging for fibroid characterization in observational studies?
How does CEUS compare to MRI in assessing uterine fibroid size, vascularity, and degeneration patterns?
Are there specific biomarkers that correlate with CEUS imaging features in fibroid subtypes like intramural or submucosal lesions?
What adverse events are associated with contrast agents used in CEUS for fibroid evaluation and how are they managed?
What are the current clinical guidelines for using CEUS in fibroid management compared to traditional ultrasound techniques?