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Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665414
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

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

Condition or disease Intervention/treatment
Endometriosis Adenomyosis Diagnostic Test: MRI Diagnostic Test: transvaginal ultrasound Diagnostic Test: transvaginal ultrasound elastography

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: MRI
    preoperative MRI
  • Diagnostic Test: transvaginal ultrasound
    preoperative transvaginal ultrasound
  • Diagnostic Test: transvaginal ultrasound elastography
    preoperative transvaginal ultrasound elastography


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665414


Locations
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Germany
University Hospital Muenster
Münster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: se D Schaefer, MD PhD University Hospital Muenster, Germany
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Responsible Party: Dr. med. Sebastian Daniel Schäfer, Head of Gynecology, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04665414    
Other Study ID Numbers: Schäfer_Adenomyosis
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data will be shared upon reasonable request according to regulations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster:
adenomyosis
endometriosis
MRI
elastography
ultrasound
hysterectomy
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Uterine Diseases