Breast CancerNCT04136496
Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study
A study testing Black-Eye Ink in people with Breast Cancer and Axillary Lymphadenitis, run by The Ottawa Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Axillary Lymphadenitis
- What is being tested?
- Black-Eye Ink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2020to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergic reaction to Black Eye Ink or any of its components
- Pregnancy
- Confirmed metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Breast Cancer, Axillary Lymphadenitis
- Being tested
- Black-Eye Ink
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black-Eye InkDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ink placed before chemotherapy (Study A) | Active comparator | In Study A, 0.5 mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy Receives: Device: Black-Eye Ink |
| Ink placed after chemotherapy (Study B) | Active comparator | In Study B, 0.5 mL of Black Eye Ink will be placed before neoadjuvant therapy Receives: Device: Black-Eye Ink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of Inked nodes, containing seed and clip
Measured: 3 years
Identification rate of Inked nodes, not containing seed
Measured: 3 years
Identification rate of Inked nodes, not containing clip
Measured: 3 years
Identification rate of Inked nodes, not containing seed or clip
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start2 Jan 2020
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Why it stopped: The study was never activated / began due to hospital staff and resources being re-allocated to support the demands of the Covid-19 global pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ottawa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Raman Verma, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136496
- Sponsor's protocol ID
- 20180569-01H
- Status last verified
- Apr 2024
- First submitted
- 2 Oct 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04136496
- Acronym / sponsor ID
- 20180569-01H
- Conditions
- Breast Cancer, Axillary Lymphadenitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never activated / began due to hospital staff and resources being re-allocated to support the demands of the Covid-19 global pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Ottawa HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ink placed before chemotherapy (Study A) | Active comparator | Device: Black-Eye InkIn Study A, 0.5 mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy |
| Ink placed after chemotherapy (Study B) | Active comparator | Device: Black-Eye InkIn Study B, 0.5 mL of Black Eye Ink will be placed before neoadjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Allergic reaction to Black Eye Ink or any of its components
- Pregnancy
- Confirmed metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black-Eye InkThere 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. | Device | Ink placed after chemotherapy (Study B), Ink placed before chemotherapy (Study A) |
Primary outcome
Identification rate of Inked nodes, containing seed and clip
Time frame: 3 years
Identification rate of Inked nodes, not containing seed
Time frame: 3 years
Identification rate of Inked nodes, not containing clip
Time frame: 3 years
Identification rate of Inked nodes, not containing seed or clip
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black-Eye Ink in people with Breast Cancer and Axillary Lymphadenitis, run by The Ottawa Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rate of Inked nodes, containing seed and clip (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.