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

Primary Purpose

Adenomyosis, Elastography, Transvaginal Ultrasound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Shear wave elastography
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenomyosis

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Adenomyosis

Uterine Fibroid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2022
Last Updated
June 10, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05419414
Brief Title
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
Official Title
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis, Elastography, Transvaginal Ultrasound, Fibroid Uterus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenomyosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Uterine Fibroid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Shear wave elastography
Other Intervention Name(s)
elastography
Intervention Description
Both groups were examined with shear wave elastography.
Primary Outcome Measure Information:
Title
Elastography data of adenomyotic lesions and fibroids
Description
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
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.
Secondary Outcome Measure Information:
Title
Ultrasonographic features of adenomyotic lesions
Description
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.
Time Frame
This part consists of transvaginal ultrasound examination in B-Mode. This examination takes up to 20 minutes.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Both pathologies belong to female reproductive system.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Istanbul University Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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29320956
Citation
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The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis

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