Axillary Reverse Mapping in Breast Cancer

NCT05040685 | Completed DMC

• 1 other identifier: PR139/21
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymph Node Cancer Metastatic

Keywords

Lymphedema; Sentinel lymph node; Axillary lymph node dissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of metastatic ARM

  1 year

Study Arms (1)

Axillary mapping reverse

EXPERIMENTAL

Application of axillary mapping reverse technique

Procedure: Axillary mapping reverse

Interventions

Axillary mapping reverse PROCEDURE

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.

Axillary mapping reverse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Carlos Ortega Expósito, MD

  Bellvitge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective not randomized pilot study to validate the axillary mapping reverse technique by using indocyanine green.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 10, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)