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Axillary Lymph Node Tattoo Marking Study

Primary Purpose

Breast Cancer, Lymph Node Metastases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SpotTM Tattoo Ink

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Lymph Node Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lymph Node SpotTM Tattoo

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cost savings

Extrapolated by calculating cost-savings of Spot™ ink vs. clipped and radioseed-labelling lymph nodes.

Full Information

NCT ID

NCT04947917

First Posted

June 24, 2021

Last Updated

January 17, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04947917

Brief Title

Axillary Lymph Node Tattoo Marking Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 29, 2021 (Actual)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lymph Node Metastases

Keywords

Breast Cancer, Lymph Node Metastases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lymph Node SpotTM Tattoo

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

SpotTM Tattoo Ink

Intervention Description

Ink injection

Primary Outcome Measure Information:

Title

Retrieval Rate

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.

Time Frame

Enrollment to completion of surgery up to 1 year

Secondary Outcome Measure Information:

Title

Cost savings

Description

Extrapolated by calculating cost-savings of Spot™ ink vs. clipped and radioseed-labelling lymph nodes.

Time Frame

Enrollment to completion of surgery up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Leah H Portnow, MD

Phone

(617) 732-6269

lportnow@bwh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leah H Portnow, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leah H Portnow, MD

Phone

617-732-6269

lportnow@bwh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Leah H Portnow, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

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Axillary Lymph Node Tattoo Marking Study

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