Axillary Lymph Node Tattoo Marking Study

NCT ID: NCT04947917

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-29
• Study Completion Date: 2023-04-13

Brief 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

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.

Conditions

Breast Cancer; Lymph Node Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SpotTM Tattoo Ink

Intervention Type: PROCEDURE

Ink injection

Interventions

SpotTM Tattoo Ink

Ink injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Leah H Portnow, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leah H Portnow, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

20-754

Identifier Type: -

Identifier Source: org_study_id