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

Breast Cancer Clinical Trial

— ARMONIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994225
• Other study ID #: 2016-A01623-48
• Secondary ID: 2016/2462
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: August 5, 2019

Study information

• Verified date: May 2022
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 5, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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