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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT02994225
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Study Start: 2017-03-10
• Primary Completion: 2019-06-07
• Study Completion: 2019-08-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Indocyanine 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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France