The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis

NCT05419414 | Completed FDA Device

• 1 other identifier: 2018/1080
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. Shear wave elastography data of both groups were compared. Features of adenomyosis on transvaginal ultrasound were also recorded for study group.

Conditions

Adenomyosis; Elastography; Transvaginal Ultrasound; Fibroid Uterus

Outcome Measures

Primary Outcomes (1)

• 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

  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

  This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.

Study Arms (2)

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.

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.

Device: Shear wave elastography

Interventions

Shear wave elastography DEVICE

Both groups were examined with shear wave elastography.

Also known as: elastography

Adenomyosis; Uterine Fibroid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Both pathologies belong to female reproductive system.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who applied to outpatient clinic due to abnormal uterine bleeding, pelvic pain, infertility.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Medicine

Istanbul, 34349, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 29320956 BACKGROUND

• 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.

  PMID: 23703939 BACKGROUND

• 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.

  PMID: 16563868 BACKGROUND

• 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.

  PMID: 26992563 BACKGROUND

• 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.

  PMID: 19790094 BACKGROUND

• 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.

  PMID: 22308105 BACKGROUND

• 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.

  PMID: 33242677 BACKGROUND

• 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.

  PMID: 29784438 BACKGROUND

• 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.

  PMID: 24316138 BACKGROUND

• 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.

  PMID: 20014360 BACKGROUND

• 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.

  PMID: 25652685 BACKGROUND

• 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.

  PMID: 27847535 BACKGROUND

MeSH Terms

Conditions

Adenomyosis; Leiomyoma

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 15, 2022
• Study Start: October 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

TU (1)