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

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT05419414
Collaborator
(none)
65
Enrollment
1
Location
2
Arms
39
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Shear wave elastography
 N/A

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

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Device: Shear wave elastography
Both groups were examined with shear wave elastography.
Other Names:
  • elastography

    		•
    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.

    Device: Shear wave elastography
    Both groups were examined with shear wave elastography.
    Other Names:
  • elastography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Elastography data of adenomyotic lesions and fibroids [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

    Secondary Outcome Measures

    1. Ultrasonographic features of adenomyotic lesions [This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Faculty of Medicine Istanbul Turkey 34349

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Muhterem Melis Cantürk, Principal Investigator, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT05419414
    Other Study ID Numbers:
    • 2018/1080
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Adenomyosis

    Study Results

    No Results Posted as of Jun 15, 2022