Breast Carcinoma
Conditions
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.
Interventions
OTHERElectronic Health Record Review
Medical record reviewed
PROCEDUREUltrasound Microvessel Imaging
Undergo 3D ultrasound microvessel imaging
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 sensitivity using McNemar's test | Up to 1 year | Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score. |
| 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 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 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 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 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 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. |
Countries
United States
Outcome results
None listed