3D Ultrasound Microvessel Imaging for Breast Masses
- Conditions
- Breast Carcinoma
- Interventions
- Other: Electronic Health Record ReviewProcedure: Ultrasound Microvessel Imaging
- Registration Number
- NCT04925817
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
- Detailed Description
PRIMARY OBJECTIVES:
I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.
OUTLINE:
Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
- Lesion size of 3 mm or larger.
- Age 18 or greater.
- Women with previous breast surgery or breast implant.
- Lacking the capacity to consent.
- Women who are pregnant or lactating.
- Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (ultrasound microvessel imaging) Electronic Health Record Review Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. Diagnostic (ultrasound microvessel imaging) Ultrasound Microvessel Imaging Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
- Primary Outcome Measures
Name Time Method Ultrasound parameters accuracy using McNemar's test Up to 1 year Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters vs. Breast Image Reporting using McNemar's test Up to 1 year Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters negative predictive value using McNemar's test Up to 1 year Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Ultrasound diagnostic accuracy using McNemar's test Up to 1 year Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Ultrasound parameters positive predictive value using McNemar's test Up to 1 year Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters specificity using McNemar's test Up to 1 year Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters calculated by McNemar's test Up to 1 year Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters sensitivity using McNemar's test Up to 1 year Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States