Assessment of the Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy and Surgery, UTMOST Trial

Overview

About this study

In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally move in patients who are receiving neoadjuvant systemic therapy for breast cancer with metastasis to the lymph nodes under the arm.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 Dr. Mara Piltin, who will decide if preoperative I-125 seed localization of the positive node is necessary or if she will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and 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 Dr. Mara Piltin.
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:

Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Christine Lee, M.D., Ph.D.	Closed for enrollment	Contact information: Christine Lee M.D., Ph.D. lee.christine@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christine Lee, M.D., Ph.D.

Closed for enrollment

Contact information:

Christine Lee M.D., Ph.D.

lee.christine@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials