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| ID | Type | Description | Link |
|---|---|---|---|
| 2016/2462 | Other Identifier | CSET number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of identification | 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. | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chafika MAZOUNI, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35840448 | Derived | Conversano A, Abbaci M, Karimi M, Mathieu MC, de Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Axillary reverse mapping using near-infrared fluorescence imaging in invasive breast cancer (ARMONIC study). Eur J Surg Oncol. 2022 Dec;48(12):2393-2400. doi: 10.1016/j.ejso.2022.07.004. Epub 2022 Jul 8. | |
| 35681595 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Abbaci M, Conversano A, Karimi M, Mathieu MC, Rouffiac V, De Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022 May 25;14(11):2614. doi: 10.3390/cancers14112614. |
| D017437 |
| Skin and Connective Tissue Diseases |