Recruiting
Phase 1

Optimized Ultrasound Marker

Sponsor:

Mayo Clinic

Code:

NCT06999798

Conditions

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Anatomic Stage IV Breast Cancer AJCC v8

Locally Advanced Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diagnostic Mammography

Resection

Ultrasound Imaging

Twinkling Marker Placement

Study Details

Brief summary:

This phase I trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.

Conditions

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Anatomic Stage IV Breast Cancer AJCC v8

Locally Advanced Breast Carcinoma

Study ID

NCT06999798

Start date

Aug 29, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Diagnostic (optimized twinkling marker placement, ultrasound)

Patients undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node, followed by additional ultrasound imaging and SOC mammography prior to starting NST. Patients also undergo optional ultrasound imaging during NST as clinically indicated. Patients then undergo surgical removal of the optimized twinkling marker during SOC surgical resection of the positive lymph node.

Interventions

Diagnostic Mammography

Undergo mammography

Resection

Undergo surgical resection of the lymph node as part of standard care.

Ultrasound Imaging

Undergo ultrasound imaging. Ultrasound images will be evaluated for presence and visibility/conspicuity of the twinkling marker.

Twinkling Marker Placement

Undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement.

Primary outcome measure

  • Conspicuity of the optimized Mayo-developed twinkling marker [ Time Frame: Baseline up to final pre-operative imaging before surgery; generally 6-9 months ]
  • Migration of the optimized Mayo-developed twinkling marker [ Time Frame: At time of surgery (baseline) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Breast and Melanoma Surgical Oncology (BSMO) Clinical Research Unit

507-538-4849BMSORESEARCH@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Shelley Fabian

507-538-4849BMSORESEARCH@mayo.edu

Principal Investigator:

Christine U. Lee, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-06.