Clinical trial · Interventional
Mayo Designed Soft Tissue Ultrasound-Detectable Marker
A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
NCT04674852CI-TRIAL-00063346completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Ultrasound Therapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Research Marker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Marking cN+ nodes
- description
- These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.
- interventionNames
- Device: Research Marker
Primary outcomes (1)
- measure
- Ultrasound detectability
- timeFrame
- Time of placement to surgical resection.
- description
- Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Secondary outcomes (1)
- measure
- Conspicuity compared to conventional biopsy markers and radioactive seeds
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node * Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node * Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN * Radioactive seed localization of an axillary lymph node. * No contraception is necessary or required. * English speaking Exclusion Criteria: * Scheduled for only radioactive seed localizations in the breast (as opposed to axilla) * Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
References
Publications (1)
- DERIVEDJakub JW, Hesley GK, Larson NB, Yaszemski MJ, Lee Miller A 2nd, Greenleaf JF, Urban MW, Lee CU. Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study. Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053. PMID 36367449