|- candidate number||16077|
|- NTR Number||NTR4402|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jan-2014|
|- Secondary IDs||2014_087 METC|
|- Public Title||The use of CEUS in the assessment of uterine fibroids, a feasibility study.|
|- Scientific Title||The use of CEUS in the assessment of uterine fibroids, a feasibility study.|
|- hypothesis||We think that CEUS has an additional value in identifying the (micro)vasculature of uterine fibroids compared to 3D power Doppler ultrasound. We hypothesize that in the future CEUS could be useful for the prediction of fibroid responsiveness for specific therapies and for the monitoring of uterine leiomyomas. We will use dynamicMRI as a reference standard.|
|- Healt Condition(s) or Problem(s) studied||Fibroids, Ultrasonography, Contrast enhanced sonography (CEUS)|
|- 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
- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2014|
|- planned closingdate||31-dec-2014|
|- Target number of participants||10|
|- Interventions||Patients will undergo a 3D power Doppler, CEUS and a MRI-scan. |
|- Primary outcome||- 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 outcome||- 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.
|- Timepoints||Patients will receive one dynamic MRI and at one timepoint a contrast sonography of the uterus.|
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES|| A. Dooper|
|- CONTACT for SCIENTIFIC QUERIES|| B. Stoelinga|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||With Contrast Enhanced UltraSound (CEUS) the microvascularisation of uterine leiomyomas can be visualized with the potential to improve ultrasound imaging for uterine leiomyoma detection. This can be useful for treatment choice and therapeutic monitoring of uterine leiomyomas. The past years numerous studies have been preformed with CEUS, but only a few small series were reported on using CEUS in the assessment of uterine leiomyomas. To our knowledge there are no studies that compare the diagnostic value of CEUS in identifying uterine leiomyomas compared to 3D power Doppler, with MRI as a reference standard, which is the aim of this current study.
Multicenter: VUmc and AMC
|- Main changes (audit trail)|
|- RECORD||16-jan-2014 - 4-jun-2014|