3D Ultrasound Microvessel Imaging for Breast Masses

Breast Carcinoma Clinical Trial

Official title:

3D Ultrasound Microvessel Imaging for Breast Masses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04925817
• Other study ID #: 21-002713
• Secondary ID: NCI-2021-04853P3
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 19, 2021
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Electronic Health Record Review
Medical record reviewed

Procedure:
• Ultrasound Microvessel Imaging
Undergo 3D ultrasound microvessel imaging

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound diagnostic accuracy using McNemar's test	Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.	Up to 1 year
Primary	Ultrasound parameters sensitivity using McNemar's test	Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.	Up to 1 year
Primary	Ultrasound parameters specificity using McNemar's test	Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.	Up to 1 year
Primary	Ultrasound parameters positive predictive value using McNemar's test	Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.	Up to 1 year
Primary	Ultrasound parameters negative predictive value using McNemar's test	Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .	Up to 1 year
Primary	Ultrasound parameters accuracy using McNemar's test	Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.	Up to 1 year
Primary	Ultrasound parameters calculated by McNemar's test	Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.	Up to 1 year
Primary	Ultrasound parameters vs. Breast Image Reporting using McNemar's test	Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.	Up to 1 year

External Links

•   Mayo Clinic Clinical Trials