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Ultrasound Imaging

3D Ultrasound Imaging for Breast Cancer

Phase < 1

Recruiting

Led By Shigao D Chen, Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18 or older

Be older than 18 years old

Must not have

Vulnerable subjects such as prisoners and adults lacking capacity to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses a new 3D ultrasound imaging technique to examine axillary lymph nodes in people with breast cancer. Ultrasound uses sound waves to create images of the body.

Who is the study for?

This clinical trial is for women over the age of 18 who have breast cancer and are scheduled to undergo a biopsy of their axillary lymph nodes, which are located near the armpits. It's not open to prisoners or adults unable to consent.

What is being tested?

The study is testing a new imaging technology called 3D ultrasound (3D-US) to see how well it can evaluate axillary lymph nodes in patients with breast cancer compared to standard imaging methods.

What are the potential side effects?

Since this trial involves non-invasive ultrasound imaging, there are minimal side effects expected. The procedure may involve some discomfort similar to that experienced during regular ultrasounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not a prisoner and can make my own health decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (3D-US)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound Imaging

2018

Completed Phase 4

~760

0 / 2Eligibility criteria met