Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity (ARMONIC)

Gustave Roussy

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT02994225

2016-A01623-48

2016/2462 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Study arm

Experimental group

Description:

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

Treatment:

Drug: Indocyanine Green