3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer
ConditionBreast Carcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
Age of 18 or older.
Disqualifiers
Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound Imaging
DeviceUndergo 3D-US
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Diagnostic (3D-US)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)
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.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov