Contrast-enhanced Ultrasound Using Intradermal Microbubble Sulfur Hexafluoride for Identification of Sentinel Lymph Nodes During Breast Cancer Surgery: A Clinical Trial.


Journal

Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988

Informations de publication

Date de publication:
Feb 2023
Historique:
received: 27 11 2022
revised: 16 12 2022
accepted: 22 12 2022
entrez: 25 1 2023
pubmed: 26 1 2023
medline: 28 1 2023
Statut: ppublish

Résumé

Sentinel lymph node (SLN) procedures have gained popularity in early breast cancer thanks to the reduction of surgical side-effects. The standard SLN mapping procedure uses AX-CES, a prospective, monocentric, single-arm phase-3 study was designed (EudraCT: 2020-000393-20). Inclusion criteria were histologically diagnosed early breast cancer eligible for upfront surgery and SLN resection, bodyweight 40-85 kg, and no prior history of ipsilateral surgery or radiotherapy. All patients underwent CEUS prior to surgery and blue dye injection was performed in areas with contrast accumulation. After the experimental procedure, all patients underwent the standard mapping procedure and SLN frozen section assessment was performed. Data on the success rate, systemic reactions, mean procedure time, CEUS appearance, SLN number, and concordance with standard mapping procedure were collected. Among 16 cases, a median of two SLNs were identified during CEUS. In all cases, at least one SLN was identified by CEUS (100%). In six cases, SLNs were classified during CEUS as abnormal, which was confirmed by definitive staining in four cases. After the standard mapping technique, in 15 out of the 16 cases (87.50%), at least one SLN from the standard mapping procedure was marked with blue dye in the CEUS procedure. In our series, sensitivity and specificity of SLN detection by CEUS were 75% and 100%, respectively. CEUS is a safe and manageable intraoperative procedure. When compared with standard techniques, US appearance during CEUS may provide additional information when associated with histological assessment.

Sections du résumé

BACKGROUND/AIM OBJECTIVE
Sentinel lymph node (SLN) procedures have gained popularity in early breast cancer thanks to the reduction of surgical side-effects. The standard SLN mapping procedure uses
MATERIALS AND METHODS METHODS
AX-CES, a prospective, monocentric, single-arm phase-3 study was designed (EudraCT: 2020-000393-20). Inclusion criteria were histologically diagnosed early breast cancer eligible for upfront surgery and SLN resection, bodyweight 40-85 kg, and no prior history of ipsilateral surgery or radiotherapy. All patients underwent CEUS prior to surgery and blue dye injection was performed in areas with contrast accumulation. After the experimental procedure, all patients underwent the standard mapping procedure and SLN frozen section assessment was performed. Data on the success rate, systemic reactions, mean procedure time, CEUS appearance, SLN number, and concordance with standard mapping procedure were collected.
RESULTS RESULTS
Among 16 cases, a median of two SLNs were identified during CEUS. In all cases, at least one SLN was identified by CEUS (100%). In six cases, SLNs were classified during CEUS as abnormal, which was confirmed by definitive staining in four cases. After the standard mapping technique, in 15 out of the 16 cases (87.50%), at least one SLN from the standard mapping procedure was marked with blue dye in the CEUS procedure. In our series, sensitivity and specificity of SLN detection by CEUS were 75% and 100%, respectively.
CONCLUSION CONCLUSIONS
CEUS is a safe and manageable intraoperative procedure. When compared with standard techniques, US appearance during CEUS may provide additional information when associated with histological assessment.

Identifiants

pubmed: 36697065
pii: 43/2/557
doi: 10.21873/anticanres.16192
doi:

Substances chimiques

Contrast Media 0
Sulfur Hexafluoride WS7LR3I1D6

Types de publication

Clinical Trial, Phase III Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

557-567

Informations de copyright

Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Auteurs

Oreste Claudio Buonomo (OC)

Breast Unit, Department of Surgical Science, Policlinico Tor Vergata University, Rome, Italy.

Marco Materazzo (M)

Breast Unit, Department of Surgical Science, Policlinico Tor Vergata University, Rome, Italy; mrcmaterazzo@gmail.com marco.materazzzo@ptvonline.it.

Marco Pellicciaro (M)

Breast Unit, Department of Surgical Science, Policlinico Tor Vergata University, Rome, Italy.

Giada Iafrate (G)

Breast Unit, Department of Surgical Science, Policlinico Tor Vergata University, Rome, Italy.

Benedetto Ielpo (B)

Hepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Barcelona, Spain.

Stefano Rizza (S)

Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Chiara Adriana Pistolese (CA)

Department of Diagnostic Imaging and Interventional Radiology, Molecular Imaging and Radiotherapy, University of Rome Tor Vergata, Rome, Italy.

Tommaso Perretta (T)

Department of Diagnostic Imaging and Interventional Radiology, Molecular Imaging and Radiotherapy, University of Rome Tor Vergata, Rome, Italy.

Rosaria Meucci (R)

Department of Diagnostic Imaging and Interventional Radiology, Molecular Imaging and Radiotherapy, University of Rome Tor Vergata, Rome, Italy.

Benedetto Longo (B)

Division of Plastic and Reconstructive Surgery, Department of Surgical Sciences, Tor Vergata University of Rome, Rome, Italy.

Valerio Cervelli (V)

Division of Plastic and Reconstructive Surgery, Department of Surgical Sciences, Tor Vergata University of Rome, Rome, Italy.

Gianluca Vanni (G)

Breast Unit, Department of Surgical Science, Policlinico Tor Vergata University, Rome, Italy.

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Classifications MeSH