Clinical trial NCT05040685: Axillary Reverse Mapping in Breast Cancer
Official title: Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymph Node Cancer Metastatic
Keywords: Lymphedema
Sentinel lymph node
Axillary lymph node dissection
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective not randomized pilot study to validate the axillary mapping reverse technique by using indocyanine green.
Primary purpose: PREVENTION

Brief summary: The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

Detailed description: Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.

In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.

HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.

Eligibility criteria: Inclusion Criteria:

Patients who will undergo ALND in the treatment of breast cancer:

* cT4a, cT4c and cT4d.
* cT4b with extensive involvement of the skin.
* cN0 with SLNB positive (pN+) that need to associate ALND:

  * cT3-T4b.
  * \>2 lymph node macrometastasis if cTis, cT1 and cT2.
  * Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
* cN1:

  * If primary surgery treatment.
  * After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
* cN2:

  * If primary surgery treatment.
  * After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
* cN3.

Exclusion Criteria:

* Patients with previous axillary surgery (except sentinel node biopsy)
* Patients who did previous axillary radiotherapy treatment.
* Patients who do not wish to participate in the study.

Primary outcomes:
measure: Rate of patients who it is possible preserve ARM nodes
timeFrame: 1 year
Secondary outcomes:
measure: Rate of metastatic ARM
timeFrame: 1 year
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
Study officials:
affiliation: Bellvitge Hospital
name: Carlos Ortega Expósito, MD
role: PRINCIPAL_INVESTIGATOR
References: