Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117410
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-25
Brief Title:
Assessing Ultrasonographic Severity of Adenomyosis
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Assessing Ultrasonographic Severity of Adenomyosis - a Feasibility and Interobserver Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AdenoStaging
Brief 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
Detailed 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 interruptedirregular 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 methods 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 eg 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 041-060 or an ICC value of 05-075 was set as moderate κ051-080 or ICC 075-09 as good and κ080 or ICC 09 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
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 interruptedirregular 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 methods 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 eg 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 041-060 or an ICC value of 05-075 was set as moderate κ051-080 or ICC 075-09 as good and κ080 or ICC 09 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None