Active, not recruiting • Phase O • Stage 0, I, II, III, IV • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
3D Ultrasound Microvessel Imaging for Breast Masses
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.
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.
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
50 participant
Actual study start date:
August 19, 2021
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
female
Arms and Intervention
Electronic Health Record Review
Ultrasound Microvessel Imaging
Inclusion criteria
women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
lesion size of 1 cm 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.