Axillary Lymph Node Tattoo Marking Study

Axillary Lymph Node Tattoo Marking Versus Biopsy Marker and Radioseed Tagging in Patients With Known Primary Breast Cancer

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Lymph Node Metastases
• Intervention / Treatment: Procedure: SpotTM Tattoo Ink

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lymph Node SpotTM Tattoo; 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.

Procedure: SpotTM Tattoo Ink; Ink injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrieval Rate	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.	Enrollment to completion of surgery up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost savings	Extrapolated by calculating cost-savings of Spot™ ink vs. clipped and radioseed-labelling lymph nodes.	Enrollment to completion of surgery up to 1 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Leah H Portnow, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Lymph Node Metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: 20-754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No