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3D Ultrasound for Lymph Node Imaging in Breast Cancer

This study is testing a new type of 3D ultrasound (3D-US) imaging to see how well it can look at lymph nodes in people with breast cancer. Ultrasound uses sound waves to create pictures inside the body. Researchers want to see if this new 3D-US can tell the difference between healthy and cancerous lymph nodes. They will also compare it to the standard 2D ultrasound. You might be able to join if you are a woman aged 18 or older with breast cancer who is having a lymph node biopsy (removing a small piece of tissue for testing) or has had a lymph node clip placed as part of your regular care. The main goal is to see how well radiologists can use this new 3D-US to diagnose lymph nodes as benign (not cancerous) or malignant (cancerous). The study's current status is unclear.

Study design
This is an interventional study with a planned enrollment of 55 participants. It is testing a new 3D ultrasound device.
What's involved
You would undergo a 3D-US scan during the study. If you have a lymph node clip and are receiving chemotherapy before surgery, you would have the clipped node imaged before your surgery.
Compensation
Not stated in the trial record.
Follow-up
Your lymph node diagnosis by a radiologist will be measured for up to 2 years.

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NCT05704283

3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Mayo Clinic
~55 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Ultrasound Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)
Measured over Up to 2 years

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Shigao D Chen, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
Age of 18 or older.

Exclusion

Vulnerable subjects such as prisoners and adults lacking capacity to consent.

What this trial measures

  • 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.