Assessing Ultrasonographic Severity of Adenomyosis

Ultrasound Clinical Trial

— AdenoStaging  

Official title:

Assessing Ultrasonographic Severity of Adenomyosis - a Feasibility and Interobserver Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117410
• Other study ID #: 2021.0035
• Status: Recruiting
• Start date: February 8, 2021
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this pilot study is to develop a feasible and quantifiable ultrasonographic method to grade the severity of adenomyosis and to determine the interobserver variation.

Description:

The investigators will conduct a prospective observational study in premenopausal women visiting the gynaecological outpatient clinic for an ultrasonographic exam. Patients are recruited when the diagnosis adenomyosis was made with transvaginal ultrasound (TVUS). Diagnosis adenomyosis requires at least one direct US feature of adenomyosis (subendometrial lines or buds, hyperechogenic islands or myometrial cysts). The sonographers obtain two-dimensional (2D) images, a grey-scale video-clip, elastography and power-doppler and micro-vascularity flow clips and images, and a three-dimensional (3D) uterine volume. The investigators will evaluate the collected images, clips and 3D-volumes with different methods to assess severity and test the feasibility and inter-observer agreement of these methods.

At the outpatient clinic, all real-time TVUS are assessed in a systematically manner by the sonographers and the presence of MUSA (Morphological Uterus Sonographic Assessment) features (subendometrial lines or buds, hyperechogenic islands or myometrial cysts, asymmetrical myometrium, globular uterus, translesional vascularity, fan-shaped shadowing, interrupted/irregular junctional zone) and an estimation of the affected myometrium, graded in mild (<25% affected myometrium), moderate (25%-50% affected myometrium) or severe (>50% affected myometrium) are reported. Clinical data, medical history, reason for visit, pain score in numeric rating scale (NRS), pictorial blood assessment chart (PBAC) score, etc. is collected.

Based on previous research and experience, four experts in gynaecological sonography select multiple offline methods using 5D Viewer software, for the evaluation and quantification of the severity of adenomyosis.

All the ultrasounds will be coded, so the assessors are blinded for patients demographics, medical history, symptomatology and the assessment by the sonographers.

Two experienced gynaecologist and one resident in gynaecology will test these methods for feasibility. Feasibility will be scored regarding technique, time and interpretation of MUSA features. The selected feasible methods will be tested for inter-observer variation. Finally a comparison of the severity evaluation by the assessors done with the new methods and the results of the severity estimation at the outpatient clinic will be made.

The method(s) that obtained a good feasibility score and good inter-observer agreement will consecutively be used in a follow-up study investigating the correlation with symptomatology, e.g. pain (NRS) and PBAC score.

Additionally, a descriptive study using the elastography and micro-vascularity flow images and clips will be performed.

The obtained data will be analysed to determine a total feasibility score, inter-observer variation and inter-test agreement. Inter-observer variation was tested with Fleiss Kappa or Intra Class Correlation Coefficient (ICC), depending on the data used. A kappa-coefficient of 0.41-0.60 or an ICC value of 05.-0.75 was set as moderate, κ0.51-0.80 or ICC 0.75-0.9 as good and κ≥0.80 or ICC ≥0.9 as excellent agreement. A Jonckheere-Terpstra test was used to test the trend of the new severity score and the estimated assessment of MUSA. Inter-test agreement was calculated with Cohens weighted Kappa (κw). For the correlation with NRS and PBAC intraclass correlation and Fleiss kappa were calculated and the mean severity outcomes were correlated with NRS and PBAC.

All women will sign an informed consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: September 2024
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• at least one direct MUSA feature (lines and buds, hyperechogenic islands, cysts)

• premenopausal, older than18 years

Exclusion Criteria:

• hormonal medication

• other reason for gynaecological symptoms, more evident than adenomyosis, e.g. deep infiltrating endometriosis, dominant uterine fibroids (>5cm, >5 myoma, intracavitary myoma), cervical or endometrial cancer.

Related Conditions & MeSH terms

• Adenomyosis
• Ultrasound

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786. — View Citation

Van den Bosch T, de Bruijn AM, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Bourne T, Timmerman D, Huirne JAF. Sonographic classification and reporting system for diagnosing adenomyosis. Ultrasound Obstet Gynecol. 2019 May;53(5):576-582. doi: 10.1002/uog.19096. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantifiable offline severity method	Method using 5D viewer to assess severity of adenomyosis offline	Baseline
Secondary	Dysmenorrhea	Painscore during menstruation, in numeric rating scale from respectively no pain to extreme pain (0-10)	Baseline
Secondary	Amount of menstrual blood loss	Evaluation of blood loss in pictorial blood assessment chart (PBAC). 0-150= normal bloodloss. >150= heavy menstrual bleeding.	Baseline
Secondary	Real-time severity estimation	Estimation of severity at outpatient clinic using MUSA features: mild (<25% affected myometrium), moderate (25-50% affected myometrium) or severe (>50% affected)	Baseline
Secondary	Numbers of MUSA features	Real-time presence of a number of individual MUSA features, as a measurement of severity of adenomyosis	Baseline