- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05419414
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
June 10, 2022 updated by: Muhterem Melis Cantürk, Istanbul University
In this prospective cohort study, the patients who were diagnosed with either uterine fibroid (control group) or adenomyosis (study group), were examined with transvaginal ultrasound and shear wave elastography.
Definitive diagnosis was established by pelvic MRI.
Shear wave elastography data of both groups were compared.
Features of adenomyosis on transvaginal ultrasound were also recorded for study group.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this prospective cohort study, the patients who applied to the Gynecology and Infertility Outpatient Clinic in Istanbul University Faculty of Medicine between October 2018 and October 2021 due to abnormal uterine bleeding, pelvic pain, infertility were evaluated.
The patients who were diagnosed with adenomyosis and uterine myoma according to clinical evaluation were included and grouped.
Clinical diagnosis were confirmed with contrast enhanced pelvic magnetic resonance imaging.
No histopathological confirmation were included in this study.
34 patients were included in adenomyosis group and 31 patients were included in myoma group.
All patients were evaluated with shear wave elastography; 3 regions of interest were selected for each elastographic evaluation.
Average shear values were determined automatically; then, minimum and maximum mean shear values were recorded accordingly.
Elastography values of both groups were compared in order to detect any statistically significant difference between 2 groups.
In addition to elastography evaluation, the compatibility of transvaginal ultrasound and magnetic resonance were evaluated.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34349
- Istanbul University Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients who applied to outpatient clinic due to abnormal uterine bleeding, pelvic pain, infertility.
Exclusion Criteria:
- Patients who are currently pregnant or has current malignancy, use combined oral contraceptives, gonadotropin releasing hormone agonist, intrauterine device or currently taking hormonal replacement therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Adenomyosis
Patients who were diagnosed with adenomyosis according to pelvic MRI were examined with transvaginal ultrasound.
Certain ultrasonographic features of adenomyosis ( asymmetrical uterine wall thickening, myometrial cysts, fan shaped lines and shadows, presence of irregular junctional zone, presence of clue sign, global enlargement) were recorded.
Then the patients were examined with shear wave elastography.
Maximum and minimum median shear wave values were recorded through the selected regions of interest.
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Both groups were examined with shear wave elastography.
Other Names:
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Active Comparator: Uterine Fibroid
Patients who were diagnosed with myoma uteri according to pelvic MRI were examined with transvaginal ultrasound.
Then the patients were examined with shear wave elastography.
Maximum and minimum median shear wave values were recorded through the selected regions of interest.
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Both groups were examined with shear wave elastography.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elastography data of adenomyotic lesions and fibroids
Time Frame: First we visualize the lesion in B-Mode ultrasound, then with the help of shear wave elastography, a color map is formed over the pathological lesion. We select 3 regions of interest to measure tissue stiffness. This takes about 15 minutes.
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By using shear wave elastography, we can calculate the stiffness of selected region of uterine pathology.
We use transvaginal ultrasound probe while performing shear wave elastography.
The selected region of interest is defined as 10 mm circular area which is selected by the ultrasonographer.
Stiffness of the tissue is calculated by elastography program which works by emitting acoustic radiofrequency impulses.
These impulses creates transversely oriented shear waves which propagates through the tissue.
The velocity of the shear waves is measured by the device and by using Young's modulus, shear wave elastography provides us a numerical value in kiloPascal.
This value gives us important information regarding the stiffness of the tissue.
For adenomyotic lesions and fibroids, shear wave elastography is performed and for each selected region of interest, a numerical value in kilopascal is given by the ultrasound and we aim to compare these data for adenomyosis and fibroid groups
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First we visualize the lesion in B-Mode ultrasound, then with the help of shear wave elastography, a color map is formed over the pathological lesion. We select 3 regions of interest to measure tissue stiffness. This takes about 15 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonographic features of adenomyotic lesions
Time Frame: This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.
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To describe the features of adenomyosis seen during the transvaginal ultrasound examination, we perform a pelvic ultrasound using transvaginal probe in B-Mode.
During the examination we analyze and record for the presence of certain features such asymmetrical uterine wall thickening, myometrial cysts, hyper echoic islands, fan-shaped shadowing, subendometrial buds and lines and irregular or interrupted junctional zone.
We recorded presence and absence of each feature for every patient in adenomyosis group.
At the end we we calculated the percentage of each feature's presence in patients diagnosed with adenomyosis.
We listed the most common and least seen feature.
We also recorded the presence of endometrioma or deep infiltrating endometriosis in order to calculate the percentage of patients in which adenomyosis and endometriosis coexist.
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This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liu X, Ding D, Ren Y, Guo SW. Transvaginal Elastosonography as an Imaging Technique for Diagnosing Adenomyosis. Reprod Sci. 2018 Apr;25(4):498-514. doi: 10.1177/1933719117750752. Epub 2018 Jan 10.
- Stoelinga B, Hehenkamp WJ, Brolmann HA, Huirne JA. Real-time elastography for assessment of uterine disorders. Ultrasound Obstet Gynecol. 2014 Feb;43(2):218-26. doi: 10.1002/uog.12519. Epub 2014 Jan 12.
- Vercellini P, Vigano P, Somigliana E, Daguati R, Abbiati A, Fedele L. Adenomyosis: epidemiological factors. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):465-77. doi: 10.1016/j.bpobgyn.2006.01.017. Epub 2006 Mar 24.
- Zhang Q, Duan J, Liu X, Guo SW. Platelets drive smooth muscle metaplasia and fibrogenesis in endometriosis through epithelial-mesenchymal transition and fibroblast-to-myofibroblast transdifferentiation. Mol Cell Endocrinol. 2016 Jun 15;428:1-16. doi: 10.1016/j.mce.2016.03.015. Epub 2016 Mar 15.
- Ami O, Lamazou F, Mabille M, Levaillant JM, Deffieux X, Frydman R, Musset D. Real-time transvaginal elastosonography of uterine fibroids. Ultrasound Obstet Gynecol. 2009 Oct;34(4):486-8. doi: 10.1002/uog.7358. No abstract available.
- Sarvazyan A, Hall TJ, Urban MW, Fatemi M, Aglyamov SR, Garra BS. AN OVERVIEW OF ELASTOGRAPHY - AN EMERGING BRANCH OF MEDICAL IMAGING. Curr Med Imaging Rev. 2011 Nov;7(4):255-282. doi: 10.2174/157340511798038684.
- Gorgulu FF, Okcu NT. Which imaging method is better for the differentiation of adenomyosis and uterine fibroids? J Gynecol Obstet Hum Reprod. 2021 May;50(5):102002. doi: 10.1016/j.jogoh.2020.102002. Epub 2020 Nov 23.
- Stoelinga B, Hehenkamp WJK, Nieuwenhuis LL, Conijn MMA, van Waesberghe JHTM, Brolmann HAM, Huirne JAF. Accuracy and Reproducibility of Sonoelastography for the Assessment of Fibroids and Adenomyosis, with Magnetic Resonance Imaging as Reference Standard. Ultrasound Med Biol. 2018 Aug;44(8):1654-1663. doi: 10.1016/j.ultrasmedbio.2018.03.027. Epub 2018 May 18.
- Shwayder J, Sakhel K. Imaging for uterine myomas and adenomyosis. J Minim Invasive Gynecol. 2014 May-Jun;21(3):362-76. doi: 10.1016/j.jmig.2013.11.011. Epub 2013 Dec 4.
- Leone FP, Timmerman D, Bourne T, Valentin L, Epstein E, Goldstein SR, Marret H, Parsons AK, Gull B, Istre O, Sepulveda W, Ferrazzi E, Van den Bosch T. Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group. Ultrasound Obstet Gynecol. 2010 Jan;35(1):103-12. doi: 10.1002/uog.7487.
- Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10.
- Acar S, Millar E, Mitkova M, Mitkov V. Value of ultrasound shear wave elastography in the diagnosis of adenomyosis. Ultrasound. 2016 Nov;24(4):205-213. doi: 10.1177/1742271X16673677. Epub 2016 Oct 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
June 7, 2022
First Submitted That Met QC Criteria
June 10, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/1080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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