Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study

April 2, 2024 updated by: Dr. Raman Verma, The Ottawa Hospital
Patients with breast cancer and metastatic axillary lymphadenopathy routinely undergo neo-adjuvant chemotherapy. For these patients, biopsy clip markers are inserted into the biopsy proven metastatic lymph node pre-treatment, as they may reach complete clinical response post-therapy. Limited axillary surgery, as opposed to a full axillary dissection, may then be indicated. It is still necessary to surgically excise the biopsy proven metastatic lymph node to accurately assess the pathologic response to therapy, and subsequently tailor post-surgical therapies appropriately. As such, these lymph nodes require pre-operative localization which, at The Ottawa Hospital, currently requires radioactive seed insertion under sonographic guidance, typically performed within 5 days of surgery. The procedure is often challenging, as both normal appearing lymph nodes and 3 mm biopsy clip markers are difficult and in some cases impossible, to visualize on ultrasound. At the time of surgery, the excised lymph node is radiographed, to ensure the radioactive seed and biopsy clip marker are both successfully excised. Localization with Ink has the potential to replace both the biopsy clip markers and radioactive seeds as the surgeons are able to directly visualize the Ink intra-operatively and excise the Inked lymph node. A preliminary study out of Stanford on 28 patients who underwent localization of axillary lymph nodes with Ink injected 1-211 days pre-operatively, in the pre neo-adjuvant and post neo-adjuvant settings, showed that lymph nodes injected with Ink are visible intra-operatively months after surgery, suggesting that this is a feasible localization technique (1).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y1J7
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English or French speaking female patients, with a personal history of current pathologically proven breast cancer, over the age of 18 years [patients <18 would be considered a rare occurrence]
  • Patients who will be undergoing neoadjuvant chemotherapy
  • Patients who will be undergoing axillary lymph node radioactive seed localization
  • Patients who will be undergoing axillary surgery

Exclusion Criteria:

  • Allergic reaction to Black Eye Ink or any of its components
  • Pregnancy
  • Confirmed metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ink placed before chemotherapy (Study A)
In Study A, 0.5 mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy
Device: Black-Eye Ink
There are two proposed studies utilizing the Ink during differing timepoints.Both will identify patients with breast cancer, with a biopsied metastatic axillary lymph node(LN) with a tissue marker clip placed, as is current practice. In Study A, 0.5mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy. In Study B, 0.5mL of Black Eye Ink will be placed before neoadjuvant therapy. In both studies, the LN containing the tissue marker clip will be the one to have the radioactive seed and Ink inserted. The seed will still be inserted, in the event the dye is not well-visualized. In both studies, the surgeon will attempt to find the LN by direct visualization and then confirm the appropriate LN has been removed by using the Gamma probe and intra-operative radiographs. If the seed is not within the tattooed node, the LN containing the seed will also be removed. All lymph nodes injected with Ink will be removed by the surgeon;no Ink-injected node remains in body.
Active Comparator: Ink placed after chemotherapy (Study B)
In Study B, 0.5 mL of Black Eye Ink will be placed before neoadjuvant therapy
Device: Black-Eye Ink
There are two proposed studies utilizing the Ink during differing timepoints.Both will identify patients with breast cancer, with a biopsied metastatic axillary lymph node(LN) with a tissue marker clip placed, as is current practice. In Study A, 0.5mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy. In Study B, 0.5mL of Black Eye Ink will be placed before neoadjuvant therapy. In both studies, the LN containing the tissue marker clip will be the one to have the radioactive seed and Ink inserted. The seed will still be inserted, in the event the dye is not well-visualized. In both studies, the surgeon will attempt to find the LN by direct visualization and then confirm the appropriate LN has been removed by using the Gamma probe and intra-operative radiographs. If the seed is not within the tattooed node, the LN containing the seed will also be removed. All lymph nodes injected with Ink will be removed by the surgeon;no Ink-injected node remains in body.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Identification rate of Inked nodes, containing seed and clip
Time Frame: 3 years
3 years
Identification rate of Inked nodes, not containing seed
Time Frame: 3 years
3 years
Identification rate of Inked nodes, not containing clip
Time Frame: 3 years
3 years
Identification rate of Inked nodes, not containing seed or clip
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20180569-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only study staff will have access to the study data. Only de-identified data will be collected in all study documents. The OHSN-REB and OHRI may review original patient medical records and relevant study records under the supervision of the investigator for audit purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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