Clinical trial NCT04136496: Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study
Official title: Evaluation of a Novel Axillary Lymph Node Ink Localization Technique: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Axillary Lymphadenitis
Lead sponsor: The Ottawa Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Identification rate of Inked nodes, containing seed and clip
timeFrame: 3 years
measure: Identification rate of Inked nodes, not containing seed
timeFrame: 3 years
measure: Identification rate of Inked nodes, not containing clip
timeFrame: 3 years
measure: Identification rate of Inked nodes, not containing seed or clip
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
References: