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OpenTrials
Completed

NCT Number: NCT04665414

Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

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

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Key information

Conditions

Endometriosis Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

preoperative MRI

Transvaginal ultrasound

Diagnostic Test

preoperative transvaginal ultrasound

transvaginal ultrasound elastography

Diagnostic Test

preoperative transvaginal ultrasound elastography

Primary outcomes

  1. sensitivity MRI

    Time frame: through study completion, an average of 1 year

    sensitivity MRI

  2. specificity MRI

    Time frame: through study completion, an average of 1 year

    specificity MRI

  3. sensitivity transvaginal ultrasound

    Time frame: through study completion, an average of 1 year

    sensitivity transvaginal ultrasound

  4. specificity transvaginal ultrasound

    Time frame: through study completion, an average of 1 year

    specificity transvaginal ultrasound

  5. sensitivity transvaginal ultrasound elastography

    Time frame: through study completion, an average of 1 year

    sensitivity transvaginal ultrasound elastography

  6. specificity transvaginal ultrasound elastography

    Time frame: through study completion, an average of 1 year

    specificity transvaginal ultrasound elastography

  7. sensitivity intraoperative ENZIAN FA

    Time frame: through study completion, an average of 1 year

    sensitivity intraoperative ENZIAN FA

  8. specificity intraoperative ENZIAN FA

    Time frame: through study completion, an average of 1 year

    specificity intraoperative ENZIAN FA

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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