Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665414
• Other study ID #: Schäfer_Adenomyosis
• Status: Completed
• Start date: September 29, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 31, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity MRI	sensitivity MRI	through study completion, an average of 1 year
Primary	specificity MRI	specificity MRI	through study completion, an average of 1 year
Primary	sensitivity transvaginal ultrasound	sensitivity transvaginal ultrasound	through study completion, an average of 1 year
Primary	specificity transvaginal ultrasound	specificity transvaginal ultrasound	through study completion, an average of 1 year
Primary	sensitivity transvaginal ultrasound elastography	sensitivity transvaginal ultrasound elastography	through study completion, an average of 1 year
Primary	specificity transvaginal ultrasound elastography	specificity transvaginal ultrasound elastography	through study completion, an average of 1 year
Primary	sensitivity intraoperative ENZIAN FA	sensitivity intraoperative ENZIAN FA	through study completion, an average of 1 year
Primary	specificity intraoperative ENZIAN FA	specificity intraoperative ENZIAN FA	through study completion, an average of 1 year
Secondary	sensitivity and specificity of single sonographic or MRI criteria or combinations thereof	sensitivity and specificity of single sonographic or MRI criteria or combinations thereof	through study completion, an average of 1 year