Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
ID05704283

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

Led by Mayo Clinic · Updated on 2025-12-26

55

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a new three-dimensional ultrasound (3D-US) imaging technology to see how well it evaluates lymph nodes in patients with breast cancer. This early phase I trial aims to improve the 3D-US technology, assess its ability to tell apart benign and malignant lymph nodes, and compare it with the traditional two-dimensional ultrasound (2D-US) method for locating clipped lymph nodes. During the study, patients will undergo 3D-US imaging. Those who have a lymph node clip placed and are receiving chemotherapy before surgery will have the clipped node imaged using the 3D-US technique. This process is designed to help optimize and evaluate the new imaging method. Participants will have their lymph nodes examined by a radiologist to determine if they are benign or malignant, with this evaluation occurring over up to two years. The study involves monitoring and imaging before surgery to gather data on the new technology's performance. The total duration of involvement varies, focusing on the imaging and diagnostic outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
  • Age of 18 or older.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 years

Participants undergo 3D ultrasound imaging to evaluate lymph nodes and compare with conventional 2D ultrasound.

Imaging visits before surgery as per clinical care

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

R

Rica Pol

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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