Axillary Reverse Mapping in Breast Cancer

Lymph Node Cancer Metastatic Clinical Trial

— ARM  

Official title:

Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040685
• Other study ID #: PR139/21
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2024
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymph Node Cancer Metastatic

Intervention

Procedure:
• Axillary mapping reverse
At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.

Locations

Country	Name	City	State
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who it is possible preserve ARM nodes	Determinate the percentage of patients who is possible preserve the ARM node during ALND	1 year
Secondary	Rate of metastatic ARM	Determinate the percentage of metastatic ARM nodes.	1 year