NCT04947917

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

June 24, 2021

Last Update Submit

January 22, 2024

Conditions

Breast CancerLymph Node Metastases

Keywords

Breast CancerLymph Node Metastases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cost savings

    Enrollment to completion of surgery up to 1 year

Study Arms (1)

Lymph Node SpotTM Tattoo

EXPERIMENTAL

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

Interventions

SpotTM Tattoo InkPROCEDURE

Ink injection

Lymph Node SpotTM Tattoo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leah H Portnow, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

December 29, 2021

Primary Completion

April 13, 2023

Study Completion

April 13, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US(1)