Breast Carcinoma
Conditions
Brief summary
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.
Detailed description
PRIMARY OBJECTIVES: I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology. II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant lymph nodes in patients. III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped lymph nodes. OUTLINE: Patients undergo 3D-US on study. Patients who have a lymph node clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.
Interventions
DEVICEUltrasound Imaging
Undergo 3D-US
Sponsors
Mayo Clinic
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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
No
Inclusion criteria
* Patients with lymph node biopsy or lymph node clip placement as per routine clinical care. * Age of 18 or older.
Exclusion criteria
* Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node diagnosis by radiologist (benign or malignant) (Aim 2) | Up to 2 years | Will characterize the lymph node as benign or malignant by reviewing images from each imaging technique based on clinical criteria including node size, shape, margin, cortical thickness, stiffness, and vascularity obtained from B-mode, shear wave elastography, and Doppler imaging. Histopathology results will be used as the ground truth to measure sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant lymph nodes. The overall agreement of the new 3dimensional (D)-ultrasound (US) method with the biopsy result will be compared to that for 2D-US using McNemar's test. For clipped lymph nodes, the performance of 2D and 3D-US will be compared for localizing the clips. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTRica Pol
PRINCIPAL_INVESTIGATORShigao D Chen, PhD
Mayo Clinic in Rochester
Outcome results
None listed