Breast Cancer
Conditions
Brief summary
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain. The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future
Interventions
DRUGIndocyanine Green
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery. Near Infra-red images acquisition is performed during surgery
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients over 18 years of age * Preoperative diagnosis of Invasive breast cancer * Patient deemed for total mastectomy with axillary lymph node dissection (ALND) * Subject capable of giving informed consent and participating in the process of consent * Affiliated to the french social security
Exclusion criteria
* Mastectomy without ALND * Previous ipsilateral axillary radiotherapy * Previous axillary surgery * Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery * Breastfeeding * Allergy to indocyanine green * Patients with a known history of reaction to iodine or iodine-containing compounds. * No consent * Impaired capacity to make informed medical decisions * Patient on guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of identification | up to 30 days | To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND. |
Countries
France
Outcome results
None listed