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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26440

Enrollment

Registered

2014-01-16

Start date

2014-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

fibroids, contrast enhanced sonography, ultrasound

Interventions

Patients will undergo a 3D power Doppler, CEUS and a MRI-scan.

Eligibility

Inclusion criteria

Inclusion criteria: Older than 18 years of age; Suspected uterine leiomyomas; scheduled for dynamic MRI

Exclusion criteria

Exclusion criteria: - Postmenopausal woman – Women with an known allergy to SonoVue or any of its components - Woman with an history of any clinically unstable cardiac condition including class III/IV cardiac failure or right to left shunts - Woman who have had a severe cardiac rhythm disorders within the last 7 days - Woman with severe pulmonary hypertension or systemic hypertension treated or not treated or women with respiratory distress syndrome – Contra-indications for dynamic MRI – Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
- To test the feasibility of CEUS in visualizing uterine leiomyomas and their vascularization. - To observe the enhancement pattern and time-intensity curve obtained from CEUS.	—

Secondary

Measure	Time frame
- Characterization of uterine leimyomas visualized with CEUS, and to describe their vascular pattern by making a micro-vascular imaging. - 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: * 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. * 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. * For 3D power Doppler PI, RI, FI, VI and VFI will be calculated.	—

Measure

Time frame

- Characterization of uterine leimyomas visualized with CEUS, and to describe their vascular pattern by making a micro-vascular imaging. - 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: * 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. * 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. * For 3D power Doppler PI, RI, FI, VI and VFI will be calculated.

—

Contacts

Public ContactA. Dooper

VUMC Boelelaan 1117

a.dooper@vumc.nl020-4443613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)