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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40659

Enrollment

Registered

2014-05-08

Start date

2014-06-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibroids myoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Characterization of uterine leiomyomas visualized with contrast enhanced ultrasound, and to describe their vascular pattern by making a micro-vascular imaging.	—

Countries

Netherlands

Outcome results