None listed
Conditions
Brief summary
Breast cancer-related lymphoedema (BCRL) is a common complication after breast cancer surgery which involves the accumulation of fluid in the arm. It affects breast cancer survivors causing discomfort, reduced function and quality of life. It occurs due to the unnecessary sacrifice of the lymphatics of the arm during sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) procedures. A SLNB is a procedure in which the sentinel lymph node (SLN) is identified, removed, and examined to determine whether cancer cells are present. A SLN is defined as the first lymph node to which cancer cells are likely spread into. An ALND is a procedure to remove lymph nodes from the axilla. Axillary reverse mapping (ARM) is a technique used to distinguish lymphatic drainage of the arm from that of the breast in the axilla by allowing surgeons to visualise lymphatic channels and nodes which drain the arm using a fluorescent tracer. The axilla and breast have mostly separate drainage pathways. ARM may allow for minimal disruption of the arm lymphatics in order to reduce the risk of BCRL during SLNB and ALND. This study aims to perform ARM using a tracer called indocyanine green (ICG) with near-infrared fluorescence imaging on patients with a positive SLNB who are undergoing ALND. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with early breast cancer and is undergoing axillary lymph node dissection. Study details: All participants in this study will complete axillary reverse mapping using ICG during the axillary lymph node dissection. This procedure will take approximately one to two hours and will be completed by a breast surgeon. Participants will then undergo removal of the tumour as standard of care, with the surgeon using an approach which has been discussed with the patient prior to surgery. This may involve removal of the tumour alone or additionally removal of the affected breast depending on the extent of the breast cancer and the patient's preferences. It is hoped that this research will aid in the understanding the anatomical relationship of ARM nodes and lymphatics, which could help predict patients at risk of lymphoedema.
Interventions
All interventions will be performed on patients with early stage clinically node negative breast cancer with a positive sentinel lymph node biopsy who are undergoing axillary lymph node dissection.
Sentinel Lymph Node Biopsy:
SLN biopsy technique will proceed as standard-of-care. This involves peri-areolar or peri-tumour subdermal injection of technetium 99m (Tc99m) and lymphoscintigraphy which is performed prior to the day of surgery. Through either a mastectomy incision or axillary incision
All interventions will be performed on patients with early stage clinically node negative breast cancer with a positive sentinel lymph node biopsy who are undergoing axillary lymph node dissection. Sentinel Lymph Node Biopsy: SLN biopsy technique will proceed as standard-of-care. This involves peri-areolar or peri-tumour subdermal injection of technetium 99m (Tc99m) and lymphoscintigraphy which is performed prior to the day of surgery. Through either a mastectomy incision or axillary incision, a handheld gamma-detecting probe will be used to identify areas of increased radioactivity within the axilla. All hot nodes will be excised. Hot SLNs are defined as any nodes with a 10:1 gamma-detecting probe ratio of SLN to non-SLNs. Excision of these nodes will occur during the appropriate mastectomy procedure (wide local excision, simple mastectomy, skin-sparing mastectomy or nipple-sparing mastectomy). This element of the procedure has a duration of approximately one hour or less. Axillary Lymph Node Dissection (ALND) & Axillary Reverse Mapping (ARM): This procedure will involve using ICG technology to observe the relationship of ARM nodes and lymphatics in addition to standard-of-care axillary lymph node dissection. Before incision, 1 mL of Infracyanine® 25mg/mL (SERB, Paris, France) will be injected subdermally into the internal bicipital sulcus of the ipsilateral arm. The injection site will be massaged until fluorescent ARM lymphatics are observed in the upper inner arm. During SLNB, a NIR fluorescence imaging system (SPY-PHI, Novadaq Technologies Inc., Mississauga, Canada) will be used to identify the ARM nodes and lymphatics. The locations of all identified ARM nodes and lymphatics will be documented in relation to axillary surgical landmarks, which include the axillary vein, thoracodorsal neurovascular bundle and second intercostobrachial nerve. The superior, medial and lateral limits of the ALND field will be the axillary vein, chest wall, and anterior edge of latissimus dorsi muscle, respectively. Nodes that fluoresce with the NIR camera will be labelled as ARM nodes. The ARM nodes within the ALND field will be removed and separately sent for histopathology. Lymph nodes outside of the ALND field will be preserved. ARM will be performed prior to ALND. ALND and ARM will both be performed during the appropriate mastectomy procedure (wide local excision, simple mastectomy, skin-sparing mastectomy or nipple-sparing mastectomy). This element of the procedure has a duration of approximately one to two hours. Mastectomy: Wide local excision, simple mastectomy, skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) with or without immediate breast reconstruction will be performed, depending on the extent of breast cancer and the patient’s preference. This will be performed as part of standard of care. This element of the procedure has a duration of approximately one to two hours. All procedures will be performed by breast surgeons at a hospital (Chris O'Brien Lifehouse).
Sponsors
Dr Sanjay Warrier
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Participant has clinically node-negative early breast cancer with a positive sentinel lymph node biopsy undergoing axillary lymph node dissection - Participant has clinically node-positive early breast cancer undergoing axillary lymph node dissection - Female, age 18 years or older - Participant understands the study procedures and can provide informed consent to participate in the study
Exclusion criteria
- Participant does not have clinically node-negative early breast cancer with a positive sentinel lymph node biopsy - Participant does not have clinically node-positive early breast cancer - Participant has known contraindication to ICG injection, i.e., previous reaction to ICG - Participant has Iodine allergy - Participant has chronic kidney disease stage 3, 4, or 5 - Participant is pregnant - Refusal to consent to participation in the study
Outcome results
None listed