3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Imaging.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
3D Ultrasound Imaging of the Axillary Lymph Nodes
Overview
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
- Device Ultrasound Imaging
Undergo 3D-US
Primary outcome measures
- Lymph node diagnosis by radiologist (benign or malignant) (Aim 2) [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05704283 · 22-006606 · NCI-2023-00106 · R01EB031040