INFRACYANINE (monopeak indocyanine green)

Key points

Favourable opinion for reimbursement in intraoperative detection of sentinel lymph nodes and lymphatic pathways in patients with breast cancer.

What therapeutic improvement?

No clinical added value in the diagnostic strategy for intraoperative detection of sentinel lymph nodes and lymphatic pathways in patients with breast cancer.

Role in the diagnostic pathway?

In breast cancer, the performance of selective Sentinel lymph node (SLN) dissection makes it possible to avoid extensive lymphadenectomy, depending on the pathology results. SLN dissection is recommended, and indicated in the event of an invasive, unifocal breast tumour of small size (< 2 cm) and in the absence of any detected malignant lymph node involvement, clinical and radiological N0 status. It can be proposed for certain cases of extensive or palpable ductal cancers in situ, treated by total mastectomy or when physicians suspect the presence of microinvasion (on radiological examinations or biopsy). In about 70% of cases where the SLN technique is indicated, the SLN is free of tumour cells, so lymphadenectomy is pointless and even harmful, since it is responsible for non-negligible morbidity, including early lymphocele and late lymphoedema, sensory and motor sequelae and aesthetic sequelae. In these defined indications, this technique makes it possible to reserve axillary lymphadenectomy for only those tumours that require it (the remaining 30%), in the event of lymph node involvement.

In breast cancer, lymphoedema is one of the most common complications of axillary lymphadenectomy, reported in 25 to 30% of patients. With the sentinel lymph node method, this percentage is estimated to be less than 10%.

The sentinel lymph node procedure was traditionally performed by dual detection using patent blue dye (PB) and a nanocolloid radiolabelled with Technetium 99 (Tc99m). However, cases of anaphylactic shock have been reported with PB, leading teams to gradually abandon this SLN identification method and to use Technetium 99-radiolabelled nanocolloids alone.

Role of the medicinal product in the care pathway:

INFRACYANINE (indocyanine green monopic) has a role in the diagnostic strategy, in the same way as nanocolloids radiolabelled with Technetium 99 (Tc99m), when the applicable guidelines recommend intraoperative detection of sentinel lymph nodes and lymphatic pathways in patients with breast cancer.