Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

April 26, 2021 updated by: Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis

comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

all patients in accordance with eligibility criteria registered to receive hysterectomy because of a suspicion of adenomyosis according to the above criteria

Description

Inclusion Criteria:

  • dysmenorrhea
  • dyspareunia
  • non cyclic lower abdominal pain
  • hypermenorrhea
  • menometrorrhaghia
  • pain while compressing the Uterus during gyn exam
  • Patient wants to participate
  • Patient will receive hysterectomy

Exclusion Criteria:

  • Patient declines to participate
  • contraindications against MRI
  • contraindications against ultrasound
  • minor
  • cannot give informed consent
  • no hysterectomy planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity MRI
Time Frame: through study completion, an average of 1 year
sensitivity MRI
through study completion, an average of 1 year
specificity MRI
Time Frame: through study completion, an average of 1 year
specificity MRI
through study completion, an average of 1 year
sensitivity transvaginal ultrasound
Time Frame: through study completion, an average of 1 year
sensitivity transvaginal ultrasound
through study completion, an average of 1 year
specificity transvaginal ultrasound
Time Frame: through study completion, an average of 1 year
specificity transvaginal ultrasound
through study completion, an average of 1 year
sensitivity transvaginal ultrasound elastography
Time Frame: through study completion, an average of 1 year
sensitivity transvaginal ultrasound elastography
through study completion, an average of 1 year
specificity transvaginal ultrasound elastography
Time Frame: through study completion, an average of 1 year
specificity transvaginal ultrasound elastography
through study completion, an average of 1 year
sensitivity intraoperative ENZIAN FA
Time Frame: through study completion, an average of 1 year
sensitivity intraoperative ENZIAN FA
through study completion, an average of 1 year
specificity intraoperative ENZIAN FA
Time Frame: through study completion, an average of 1 year
specificity intraoperative ENZIAN FA
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
Time Frame: through study completion, an average of 1 year
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: se D Schaefer, MD PhD, University Hospital Muenster, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schäfer_Adenomyosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

data will be shared upon reasonable request according to regulations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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