Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Completed
• CT.gov ID: NCT04665414
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Actual Duration (Months): 40.1
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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	Phase
Endometriosis; Adenomyosis	Diagnostic Test: MRI; Diagnostic Test: transvaginal ultrasound; Diagnostic Test: transvaginal ultrasound elastography

Study Design

• 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: Sep 29, 2017
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Jan 31, 2021

Outcome Measures

Primary Outcome Measures

1. sensitivity MRI [through study completion, an average of 1 year]

   sensitivity MRI

2. specificity MRI [through study completion, an average of 1 year]

   specificity MRI

3. sensitivity transvaginal ultrasound [through study completion, an average of 1 year]

   sensitivity transvaginal ultrasound

4. specificity transvaginal ultrasound [through study completion, an average of 1 year]

   specificity transvaginal ultrasound

5. sensitivity transvaginal ultrasound elastography [through study completion, an average of 1 year]

   sensitivity transvaginal ultrasound elastography

6. specificity transvaginal ultrasound elastography [through study completion, an average of 1 year]

   specificity transvaginal ultrasound elastography

7. sensitivity intraoperative ENZIAN FA [through study completion, an average of 1 year]

   sensitivity intraoperative ENZIAN FA

8. specificity intraoperative ENZIAN FA [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 [through study completion, an average of 1 year]

   sensitivity and specificity of single sonographic or MRI criteria or combinations thereof

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Muenster	Münster	NRW	Germany	48149

Sponsors and Collaborators

• University Hospital Muenster

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 11, 2020
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Head of Gynecology, University Hospital Muenster: adenomyosis; endometriosis; MRI; elastography; ultrasound; hysterectomy
• Additional relevant MeSH terms: Endometriosis; Adenomyosis

Study Results

No Results Posted as of Apr 28, 2021