Stopped: Institutional standard of care regarding axillary management changed. Decision was made to close the study early.
United States10 participantsStarted 2021-12-29
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Any patient presenting with a new diagnosis of breast cancer or with imaging findings highly suspicious for breast cancer (BI-RADSĀ® 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 ā¤2 (Karnofsky ā„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 alreā¦
What they're measuring
1
Retrieval Rate
Timeframe: Enrollment to completion of surgery up to 1 year