Optimized ultrasound twinkling marker to image axillary lymph nodes in clinically node-positive breast cancer
A Phase 1 Study in Patients With Clinically Node-Positive Breast Cancer to Assess the Safety, Ultrasound Conspicuity, and Migration of an Optimized Ultrasound Twinkling Marker Observed for Sonographic Targeting (UTMOST2 Trial)
This trial tests an improved ultrasound twinkling marker to help doctors reliably see cancer-containing lymph nodes by ultrasound in people with biopsy-proven node-positive breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06999798 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with biopsy-proven malignant involvement of an axillary lymph node who are scheduled for surgical management at Mayo Clinic in Rochester and can comply with study procedures are ideal candidates.
Not a fit: People without axillary node involvement, those not planning surgical removal of the targeted node, or those unable to undergo ultrasound imaging are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the marker could make ultrasound localization of positive lymph nodes more reliable, reducing missed markers and improving surgical guidance.
How similar studies have performed: Preliminary and pilot work on ultrasound twinkling markers has suggested improved marker visibility, but this optimized marker is a novel iteration that still requires clinical testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- 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
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.