Clinical trial · Interventional
Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- 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
- interventionNames
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- Rate of identification
- timeFrame
- up to 30 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDConversano 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. PMID 35840448
- DERIVEDAbbaci 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. PMID 35681595