The use of CEUS in the assessment of uterine fibroids, a feasibility study

Completed

• Conditions: fibroids; myoma; 10038595

• Registration Number: NL-OMON40659
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

-Older than 18 years of age
-Suspected uterine leiomyomas
-Signed informed consent

Exclusion Criteria

-Postmenopausal woman
- Woman with an known allergy to SonoVue or any of its components
-Servere hartdissease or recent unset of rhytmic disorders
-Contraindications for MRI

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>3D power Doppler and contrast enhanced ultrasound will be performed at women<br /><br>with a clinical suspicion of uterine leiomyomas on TVU and these results will<br /><br>be compared with dynamic MRI. The primary outcomes of the current pilot study<br /><br>are testing the feasibility of CEUS in visualizing uterine leiomyomas and their<br /><br>vascularization, assess the accuracy of CEUS in the detection of uterine<br /><br>leiomyomas and the number of leiomyomas detected with CEUS and to observe the<br /><br>enhancement pattern and time-intensity curve obtained from CEUS of which<br /><br>parameters of quantification of vascularization will be calculated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Characterization of uterine leiomyomas visualized with contrast enhanced<br /><br>ultrasound, and to describe their vascular pattern by making a micro-vascular<br /><br>imaging.</p><br>