Optimized ultrasound twinkling marker to image axillary lymph nodes in clinically node-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I study places an optimized ultrasound twinkling marker near or in biopsy-proven positive axillary lymph nodes and images them with ultrasound before surgical removal. Some patients may also have standard localization (I-125 seed) per surgeon preference, and all targeted nodes and markers are removed at surgery for confirmation. The study documents ultrasound visibility over time and correlates imaging findings with the surgical and pathology record. Outcomes focus on marker visibility and practical usability for preoperative and intraoperative ultrasound guidance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
* Surgical management will be determined by the surgeon, who will decide if preoperative Iodine (I)-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and optimized twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation
* Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Doctor \[Dr.\] Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Shon Black)
* Patients must be able to understand the study procedures and comply with them for the entire length of the study
* No contraception is necessary or required

Exclusion Criteria:

* Patients who are pregnant
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
* Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Christine U. Lee, MD, PhD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.