Axillary Lymph Node Tattoo Marking Study

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    80
  • sponsor
    Dana-Farber Cancer Institute
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Updated on 24 March 2022
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core needle biopsy

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

Description

This research study is a Feasibility Study, in which investigators are examining SpotTM ink to find out if retrieval rates of the inked lymph node at surgery are as good as or better than the standard of care, which is to clip and then radioseed-label the positive axillary lymph node.

This research study involves placement of SpotTM ink on the surface of the lymph node at the time of sampling. As per standard of care, if the lymph node is positive for malignant cells, the surgeon will remove the lymph node at the time of surgical excision. The lymph node tissue will then be evaluated by the pathologist.

The U.S. Food and Drug Administration (FDA) has approved SpotTM ink for use in the large intestine to mark colon polyps. The FDA has not approved SpotTM ink for use in axillary lymph nodes. However, SpotTM ink has been used in axillary lymph nodes by other institutions in smaller studies similar to this one with success in retrieving the lymph node after surgery.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will be in this research study until surgical removal of their breast cancer and lymph nodes after their tattoo ink placement.

It is expected that about 80 people will take part in this research study.

Details
Condition Breast Cancer, Lymph Node Metastases
Treatment SpotTM Tattoo Ink
Clinical Study IdentifierNCT04947917
SponsorDana-Farber Cancer Institute
Last Modified on24 March 2022

Eligibility

 Yes No Not Sure

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
Ability to understand and the willingness to sign a written informed consent document
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

Exclusion Criteria

Exclusion criteria includes patients who have upper body or ipsilateral arm tattoos, as
Participants with uncontrolled intercurrent illness
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 psychiatric illness/social situations that would limit compliance
with study requirements
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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