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

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ClinicalTrials.gov Identifier: NCT04136496
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Raman Verma, The Ottawa Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Axillary Lymphadenitis Device: Black-Eye Ink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study A: 10-20 patients Study B: 25-50 patients

Study B will incorporate more patients as this is the population which we are more interested in, and will benefit the greatest from this technique. Study A is to determine if it is technically feasible and obtain feedback from the surgeons

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Identification rate of Inked nodes, containing seed and clip [ Time Frame: 3 years ]
  2. Identification rate of Inked nodes, not containing seed [ Time Frame: 3 years ]
  3. Identification rate of Inked nodes, not containing clip [ Time Frame: 3 years ]
  4. Identification rate of Inked nodes, not containing seed or clip [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136496


Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y1J7
Contact: Nicole Mikhael, CCRP    61379845555 ext 17520    nimikhael@ohri.ca   
Principal Investigator: Raman Verma, MD         
Sponsors and Collaborators
The Ottawa Hospital
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Responsible Party: Dr. Raman Verma, Principal Investigator, The Ottawa Hospital
ClinicalTrials.gov Identifier: NCT04136496    
Other Study ID Numbers: 20180569-01H
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphadenitis
Lymphatic Diseases