Clinical trial · Interventional
Axillary Lymph Node Tattoo Marking Study
Axillary Lymph Node Tattoo Marking Versus Biopsy Marker and Radioseed Tagging in Patients With Known Primary Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Institutional standard of care regarding axillary management changed. Decision was made to close the study early.
Summary
Brief summary (as posted)
This research study investigates if SpotTM ink can help breast surgeons retrieve sampled lymph node as well as or better than the standard clip and radioseed guidance methods. The names of the novel study intervention involved in this study is: * SpotTM ink tattooing The names of the standard of care study interventions involved in this study are: * Core needle biopsy and/or fine needle aspiration * Surgical Removal of the Lymph Nodes via clip and radioseed guidance
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SpotTM Tattoo Ink | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymph Node SpotTM Tattoo
- description
- Spot™ ink tattooing will be administered once prior to surgery. Initial test set of participants with previous sampled lymph nodes positive for metastasis will have SpotTM ink administered at time of standard of care pre-surgery radioseed localization. A feasibility set of participants will have SpotTM ink administered at time standard of care lymph nodes sampling.
- interventionNames
- Procedure: SpotTM Tattoo Ink
Primary outcomes (1)
- measure
- Retrieval Rate
- timeFrame
- Enrollment to completion of surgery up to 1 year
- description
- The primary endpoint is feasibility. Feasibility will be defined by the successful intra-operative rate of retrieval of the lymph nodes tagged by SpotTM ink versus the clip and radioseed.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Any patient presenting with a new diagnosis of breast cancer or with imaging findings highly suspicious for breast cancer (BI-RADS® 4C and 5) and suspicious axillary lymph node(s) is potentially eligible. Inclusion criteria are those eligible patients who have axillary lymph node(s) that are suspicious by imaging. Evaluation of the axilla with US will be performed when clinically warranted, with lymph node sampling recommended by the radiologist based on morphologically abnormal features. * Age 18 years. Because no dosing or adverse event data are currently available on the use of Spot™ ink in participants \<18 years of age, children are excluded from this study. Patients must be able to undergo breast imaging and surgical procedures, and therefore have a ECOG performance status ≤2 (Karnofsky ≥60%). * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better. * Women who are pregnant or lactating are eligible as Spot™ ink is placed focally in the axillary lymph node and breast tissues. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Exclusion criteria includes patients who have upper body or ipsilateral arm tattoos, as that ink may already be present in regional nodes and may confound visibility of Spot™ ink \[19\]. If NAC has already been initiated and the lymph node is no longer visualized, tattooing will not be performed, and that patient will also be excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Spot™ ink. * Participants with uncontrolled intercurrent illness. * Participants with psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available