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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 23, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06999798). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). 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. Interventions: PROCEDURE: Diagnostic Mammography; PROCEDURE: Resection; PROCEDURE: Ultrasound Imaging; DEVICE: Twinkling Marker Placement. Primary outcome measures: Conspicuity of the optimized Mayo-developed twinkling marker , Baseline up to final pre-operative imaging before surgery; generally 6-9 months; Migration of the optimized Mayo-developed twinkling marker , At time of surgery (baseline). 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.