An interventional study of Real-time elastography and Shear wave elastography in Breast Diseases, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic
Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.
Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not.
Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.
Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not. However, employing RTE and SWE using the same equipment to directly compare elasticity measurements of a breast lesion has not been done. Investigators propose to prospectively investigate inter-observer agreement of each modality.
The study will investigate and compare the accuracy and reproducibility of SWE and RTE in the characterization of breast lesions. Furthermore, we plan to establish learning curves for RTE and SWE.
In this project, investigators will compare RTE and SWE concerning their potential to discriminate benign breast lesions from breast cancer. Investigators aim is to identify which modality will allow clinicians the best possible patient care.
153 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.
This study's enrollment of 98 is below the median of 120 across 95 interventional studies indexed under Breast Diseases.
Browse Breast Diseases studies →University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
98 patients with breast lesion will a receive breast ultrasound (real time elastography)
Diagnostic Test: Real-time elastography
98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)
Diagnostic Test: Shear wave elastography
Breast ultrasound with real-time elastography
Breast ultrasound with shear wave elastography
assessment of dignity of breast lesion by use of real-time elastography
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
Time frame: at baseline
assessment of dignity of breast lesion by use of shear wave elastography
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
Time frame: at baseline
Examinators learning curve
Establish learning curves for real-time elastography and shear wave elastography
Time frame: baseline until year 1
Ran from Mar 2018 to primary completion in Dec 2021, 45 months.
Of 29 interventional studies with no phase under Breast Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 65. This study's 45 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →