Diagnostic value of ultrasound elastography in differentiating malignant and benign lesions of the breast with combined use of real time shear wave elastography and compression elastography compared to MRI.

Not Applicable

Recruiting

• Conditions: C50; D24; Malignant neoplasm of breast; Benign neoplasm of breast

• Registration Number: DRKS00029005
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 292

Inclusion Criteria

Patient capable of giving consent.
- MR mammography performed with histologically confirmed findings, planned biopsy or clearly benign findings in mammography and sonography that can be clearly assigned to an entity.
- MR examination maximum 4 weeks ago.
- Patient has a regular appointment for MR examination or other scheduled examination in the Radiology Department of the University Women's Hospital.
- Age =18 years.
- Written informed consent from the patient.

Exclusion Criteria

- Pregnant or breastfeeding patients.
- Significantly restricted examination conditions (lying on the back is not possible, limited abduction or elevation of the arm).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the diagnostic value of elastography using real-time shear wave elastography and compression elastography simultaneously versus MR mammography in the detection and characterization of intramammary lesions.

Secondary Outcome Measures

Name	Time	Method
- Does direct comparison between real-time shear wave elastography and compression elastography improve diagnostic performance compared with MRI?<br>- Can elastography or MR mammography provide clues to the histopathology of benign and malignant lesions?<br>- What additional time is involved in using both elastography modes, in addition to B-mode ultrasonography?<br>- Are there differences in diagnostic accuracy of elastography depending on tumor histology?