Optimize settings for contrast-enhanced ultrasound imaging of uterine disorders to obtain quantifiable images
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of the contrast-enhanced images. Images will be marked 'high-quality /
sufficient quality / insufficient quality'. The high- and sufficient quality
images will be further analysed.
Secondary outcome
- Enhancement pattern and microvascular architecture of uteri (subjective
description)
- Full quantification of blood flow parameters from time-intensity curves, such
as peak enhancement (maximal level of enhancement, associated with relative
blood volume), rise time (time from baseline to peak enhancement, related to
blood flow velocity), and wash-in rate (peak enhancement/rise time) using
VueBox software (Bracco) and customized software by prof. M. Mischi (TU
Eindhoven).
- Power calculation for further research
Background summary
The smallest blood vessels in our body contain important information. This
architecture of this so-called microvasculature, the level of angiogenesis,
blood flow patterns, blood flow velocity provide much information about the
specific tissue or disorder. The microvasculature of benign disorder is, for
example, different from malignant disorders. Conventional sonography and
Doppler can only image the larger vessels. Contrast-enhanced ultrasonongraphy,
by means of intravenously injected contrast agents, is capable of imaging the
microvasculature. In addition, contrast-enhanced images can be fully
quantified. The detailed information and quantification support an accurate
diagnosis of for instance adenomyosis and sarcoma. Adenomyosis is a benign
uterine disorder that is often missed. Whereas a sarcoma is a rare malignancy
that cannot be discrimated from the common benign myoma (fibroid) using current
imaging techniques.
Study objective
Optimize settings for contrast-enhanced ultrasound imaging of uterine disorders
to obtain quantifiable images
Study design
A prospective, observational pilot study to optimize the CEUS settings with 30
women who visit the out-patient gynaecology clinic between February 1rst, 2021
and January 31rst, 2024. An initial conventional sonography exam will be
performed in line with standard clinical care. After informed consent women an
appointment will be made for the contrast-enhanced ultrasound.
Study burden and risks
There is a small anticipated risk for participants. After the use of SonoVue in
tens of thousands of patients, adverse events appear to consist of transient
alteration of taste, headache, local pain at the injection site and facial or
general flush. These side effects are in general transient, mild and rare. In
extreme rare cases an allergic reaction to the contrast agent is described.
Patients will be informed of the risk and it will be described in the study
information.
The burden for the participants is low as well. For the current study they
undergo one CEUS scan. Though permission will be asked if they may be contacted
in the future for a potential following clinical studies.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- 18 years of age or older
- abnormal uterine bleeding complaints
- signed informed consent
Exclusion criteria
- Woman with known allergy to SonoVue or any of its components
- Severe heart disease or recent unset of rhythmic disorders
- Pregant women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71846.029.19 |