- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994225
Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity (ARMONIC)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Val De Marne
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Villejuif, Val De Marne, France, 94805
- Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study arm
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of identification
Time Frame: 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.
|
up to 30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chafika MAZOUNI, MD, Gustave Roussy, Cancer Campus, Grand Paris
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01623-48
- 2016/2462 (Other Identifier: CSET number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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