AdenomyosisNCT05419414
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
A study testing Shear wave elastography in people with Adenomyosis and Elastography, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adenomyosis, Elastography, Transvaginal Ultrasound
- What is being tested?
- Shear wave elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who applied to outpatient clinic due to abnormal uterine bleeding, pelvic pain, infertility.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Medicine
Istanbul, 34349
About this study
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.
Read the 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.
- Conditions
- Adenomyosis, Elastography, Transvaginal Ultrasound, Fibroid Uterus
- Being tested
- Shear wave elastography
- Medical subject headings
- Adenomyosis, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastographyDevice
Also called elastography
Both groups were examined with shear wave elastography.
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis | Active comparator | 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. Receives: Device: Shear wave elastography |
| Uterine Fibroid | Active comparator | 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. Receives: Device: Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography data of adenomyotic lesions and fibroids
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
Measured: 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.
Secondary outcomes (1)
Ultrasonographic features of adenomyotic lesions
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.
Measured: This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Oct 2018
- Primary completion1 Oct 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhterem Melis Cantürk, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419414
- Sponsor's protocol ID
- 2018/1080
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 29320956Stoelinga 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.
PubMed 23703939Vercellini 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.
PubMed 16563868Zhang 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.
PubMed 26992563Ami 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.
PubMed 19790094Sarvazyan 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.
PubMed 22308105Gorgulu 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.
PubMed 33242677Stoelinga 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.
PubMed 29784438Shwayder 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.
PubMed 24316138Leone 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.
PubMed 20014360Van 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.
PubMed 25652685Acar 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.
PubMed 27847535
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
- ClinicalTrials.gov ID
- NCT05419414
- Acronym / sponsor ID
- 2018/1080
- Conditions
- Adenomyosis, Elastography, Transvaginal Ultrasound, Fibroid Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis | Active comparator | Device: Shear wave elastographyPatients 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. |
| Uterine Fibroid | Active comparator | Device: Shear wave elastographyPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who applied to outpatient clinic due to abnormal uterine bleeding, pelvic pain, infertility.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear wave elastographyAlso: elastographyBoth groups were examined with shear wave elastography. | Device | Adenomyosis, Uterine Fibroid |
Primary outcome
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.
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
1 secondary outcome
Ultrasonographic features of adenomyotic lesions
Time frame: This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 29320956Liu 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.
- Background: PubMed 23703939Stoelinga 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.
- Background: PubMed 16563868Vercellini 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.
- Background: PubMed 26992563Zhang 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.
- Background: PubMed 19790094Ami 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.
- Background: PubMed 22308105Sarvazyan 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.
- Background: PubMed 33242677Gorgulu 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.
- Background: PubMed 29784438Stoelinga 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.
- Background: PubMed 24316138Shwayder 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.
- Background: PubMed 20014360Leone 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.
- Background: PubMed 25652685Van 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.
- Background: PubMed 27847535Acar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear wave elastography in people with Adenomyosis and Elastography, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419414, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.