Primary objective:1) To determine the discriminating ability of the microvasculature between uteri with adenomyosis, myomas and no uterine disorders. Secondary Objectives: 2) To determine the discriminating ability of the microvasculature between…
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood flow parameters (e.g. arrival time, peak intensity, wash-out time)
obtained from time-intensity curves of adenomyosis, myomas and uteri without a
disorder.
Secondary outcome
- Blood flow parameters of sarcomas
- CEUS enhancement characteristics (e.g. homogeneity, order of enhancement,
echogenicity) of adenomyosis, fibroids, sarcoma and uteri without disorders
- Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of
detecting uterine disorder based on:
o CEUS classification model for adenomyosis
o CEUS classification model for sarcomas
o Conventional ultrasound (assessment of the gynecologist)
o MRI (assessment of the radiologist)
o Histology (assessment of the pathologist)
o Combination of all diagnostic tests used in the patient, including clinical
presentation (assessment of the gynecologist)
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 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 larger blood 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 on conventional ultrasonography. Whereas
a sarcoma is a rare malignancy that cannot be discrimated from the common
benign myoma (fibroid) using current imaging techniques.
Study objective
Primary objective:
1) To determine the discriminating ability of the microvasculature between
uteri with adenomyosis, myomas and no uterine disorders.
Secondary Objectives:
2) To determine the discriminating ability of the microvasculature between
uterine sarcoma and myomas.
3) To compare the diagnostic performance between a) CEUS; b) conventional
ultrasound; c) MRI; d) histology.
Study design
A prospective, observational study where contrast-enhanced ultrasonography will
be performed on 253 subjects who visit the outpatient Gynaecology clinic at
Amsterdam UMC, location AMC, or UZ Leuven, Belgium, between January 1st, 2024
and January 1st, 2029.
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 have shown to consist of
transient alteration of taste, head ache, 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.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- >18 years of age
- Have a uterus
- Signed Informed Consent
Exclusion criteria
- Pregnant women
- Known allergy to SonoVue or any of its components
- Severe heart disease or recent onset of cardiac rhythm disorders
- Severe pulmonary hypertension
- Use of angiogenesis inhibitor
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 | NL83391.018.23 |