Using 3D ultrasound to evaluate lymph nodes in breast cancer patients
3D Ultrasound Imaging of the Axillary Lymph Nodes
This study is testing a new 3D ultrasound technology to see if it can better identify lymph nodes in breast cancer patients compared to the standard 2D ultrasound.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05704283 on ClinicalTrials.gov |
What this trial studies
This early phase I study investigates the effectiveness of a new 3D ultrasound (3D-US) imaging technology for assessing lymph nodes in patients diagnosed with breast cancer. The primary objectives include optimizing the performance of the 3D-US technique and evaluating its ability to distinguish between benign and malignant lymph nodes. Additionally, the study aims to compare the new 3D-US method with traditional two-dimensional ultrasound (2D-US) for locating lymph nodes that have been clipped during treatment. Patients will undergo 3D ultrasound imaging before their surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 or older who have undergone lymph node biopsy or have had a lymph node clip placed as part of their clinical care.
Not a fit: Patients who are unable to provide consent or are classified as vulnerable, such as prisoners, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in evaluating lymph nodes, potentially enhancing treatment decisions for breast cancer patients.
How similar studies have performed: While this approach is innovative, it builds on existing ultrasound imaging techniques; however, the specific application of 3D ultrasound for this purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Shigao D Chen, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.