Ultrasonographic Axillary Localization

NCT ID: NCT04644848

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-04-30

Brief Summary

Breast cancer is the most common cancer of women. Surgery for early breast cancer includes axillary lymph nodes staging. Axillary surgery may lead to intractable complications like permanent arm swelling. Axillary sentinel lymph node biopsy (SLNB) has been introduced to minimize the incidence of these complications. Several methods are routinely used for identification of the sentinel node during operation. Some of these methods necessitate facilities that are not universally available; specially in countries with limited resources. In its simplest form, SLNB using the methylene blue dye technique has an identification rate of 88-94%. If the sentinel node can not be identified, full axillary dissection may be required and the risk of arm swelling is increased. The objective of this study is to maximize the identification rate of the sentinel node thus avoiding the need for extensive axillary surgery. The investigators assumed that preoperative tattooing of the suspicious lymph node during ultrasonographical imaging may help the surgeon in localizing the sentinel lymph node. In this study, the sonographer will perform preoperative tattooing of the suspicious node. The surgeon will perform SLNB by the methylene blue dye. The sensitivity of ultrasonographical tattooing relative to SLNB will be calculated. The study will determine if the tattooing technique may localize additional nodes that are missed by the methylene blue.

Detailed Description

Introduction Axillary nodal staging is an integral part of breast cancer management. Sentinel lymph node biopsy (SLNB) has become a standard of care in patients with clinically negative axillae. Various methods have been investigated to decrease the false negative rate of SLNB. Ultrasonography is an established tool for preoperative axillary staging. The diagnostic accuracy of B-mode ultrasonographic criteria and of US-guided FNAC (Fine Needle Aspiration Cytology) has been described in the literature and its role in preoperative axillary staging has been emphasized.

Ultrasonographic aspiration of suspicious axillary nodes are widely used to identify axillary metastases and obviate the need for SLNB. Previous studies retrospectively examined the concordance of ultrasonographic identification of suspicious lymph nodes with subsequent SLNB results. However, ultrasonographic axillary staging have not been prospectively compared to SLNB. In addition, concomitant ultrasonographic and SLNB are thought to increase the overall accuracy of axillary staging.

In this study, the investigators will perform preoperative ultrasonographic axillary evaluation and tattooing of suspicious lymph nodes followed by SLNB with methylene blue technique. Head-to-head and node-to-node comparison of ultrasonographic and surgical staging will be conducted.

Specific aims

1. Determination of the diagnostic accuracy of preoperative ultrasonic guided tattooing of suspicious axillary lymph nodes.

2. Determination of node-to-node concordance of ultrasonographic tattooing relative to blue dye SLNB.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pre-sentinel node biopsy ultrasonographical tattooing

Preoperative ultrasonographical tattooing of the suspicious lymph nodes. Sentinel Lymph Node Biopsy (SLNB),

Group Type: EXPERIMENTAL

Ultrasonographical tattooing of suspicious axillary lymph nodes.

Intervention Type: DIAGNOSTIC_TEST

Patients with clinically negative axillae scheduled for sentinel lymph node biopsy (SLNB) will have axillary ultrasonographical imaging of the ipsilateral axilla with a high-frequency linear probe. Suspicious lymph nodes are identified according to any of the following criteria:

• Round shape.
• Cortical thickness > 3 mm
• Eccentric cortical thickness.
• Loss of hilum.

For each patient, node dimensions and the presence of each of the above-mentioned criteria are recorded. Tattooing of all suspicious nodes is done using I ml of sterile liquid charcoal.

Sentinel lymph node biopsy

Intervention Type: PROCEDURE

Sentinel node biopsy is performed with peri-areolar subdermal injection of 3 ml methylene blue 5%. The lymphatics are tracked to the first blue lymph node. All blue, enlarged and /or tattooed nodes are separately biopsied and labelled as SLN and/or tattooed node.

Histopathological examination of the axillary nodes

Intervention Type: DIAGNOSTIC_TEST

All tattooed nodes are excised and sent to frozen section examination; labelled tattoo node.

All enlarged or blue stained nodes are excised and sent to frozen section examination; labelled sentinel node.

All nodes are bisected and a single 5 um section examined. All frozen section examinations are followed by routine paraffin section examination.

Further axillary management

Intervention Type: PROCEDURE

Further axillary management is performed as per institutional guidelines. If SLNB is negative, no further surgery is required. Axillary lymph node dissection is performed if sentinel lymph node is positive or not identified. Management of positive SLNB as per the American College Of Surgeons' Oncology Group (ACOSOG) Z0011 protocol is not currently adopted on routine basis at the investigators' institution. In this study, patients with tattooed nodes with positive histopathological findings are offered full axillary dissection even if their sentinel nodes are negative.

Interventions

Ultrasonographical tattooing of suspicious axillary lymph nodes.

Patients with clinically negative axillae scheduled for sentinel lymph node biopsy (SLNB) will have axillary ultrasonographical imaging of the ipsilateral axilla with a high-frequency linear probe. Suspicious lymph nodes are identified according to any of the following criteria:

• Round shape.
• Cortical thickness > 3 mm
• Eccentric cortical thickness.
• Loss of hilum.

For each patient, node dimensions and the presence of each of the above-mentioned criteria are recorded. Tattooing of all suspicious nodes is done using I ml of sterile liquid charcoal.

Intervention Type: DIAGNOSTIC_TEST

Sentinel lymph node biopsy

Sentinel node biopsy is performed with peri-areolar subdermal injection of 3 ml methylene blue 5%. The lymphatics are tracked to the first blue lymph node. All blue, enlarged and /or tattooed nodes are separately biopsied and labelled as SLN and/or tattooed node.

Intervention Type: PROCEDURE

Histopathological examination of the axillary nodes

All tattooed nodes are excised and sent to frozen section examination; labelled tattoo node.

All enlarged or blue stained nodes are excised and sent to frozen section examination; labelled sentinel node.

All nodes are bisected and a single 5 um section examined. All frozen section examinations are followed by routine paraffin section examination.

Intervention Type: DIAGNOSTIC_TEST

Further axillary management

Further axillary management is performed as per institutional guidelines. If SLNB is negative, no further surgery is required. Axillary lymph node dissection is performed if sentinel lymph node is positive or not identified. Management of positive SLNB as per the American College Of Surgeons' Oncology Group (ACOSOG) Z0011 protocol is not currently adopted on routine basis at the investigators' institution. In this study, patients with tattooed nodes with positive histopathological findings are offered full axillary dissection even if their sentinel nodes are negative.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Biopsy-proven invasive breast adenocarcinoma.
• Clinically non palpable axillary lymph nodes.
• T0-3, N0, M0
• Scheduled for definitive surgery.

Exclusion Criteria

• Patient unwilling to participate.
• Contraindication to methylene blue technique: hypersensitivity, pregnancy.
• T4 primary tumor.
• Previous axillary surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Osama Hussein

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Oncology Center

Al Mansurah, DK, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Osama Hussein, MD, PhD

Role: CONTACT

osamahussein@mans.edu.eg

+201099815110

Facility Contacts

Osama Hussein, MD,PhD,FEBS

Role: primary

osamahussein@mans.edu.eg

+2010 9981 5110

References

Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Cheon H, Lee SM, Cho SH, Shin KM, Kim GC. Ultrasound-Guided Fine-Needle Aspiration of Non-palpable and Suspicious Axillary Lymph Nodes with Subsequent Removal after Tattooing: False-Negative Results and Concordance with Sentinel Lymph Nodes. Ultrasound Med Biol. 2017 Nov;43(11):2576-2581. doi: 10.1016/j.ultrasmedbio.2017.07.011. Epub 2017 Aug 19.

Reference Type: BACKGROUND

PMID: 28830644 (View on PubMed)

Li J, Chen X, Qi M, Li Y. Sentinel lymph node biopsy mapped with methylene blue dye alone in patients with breast cancer: A systematic review and meta-analysis. PLoS One. 2018 Sep 20;13(9):e0204364. doi: 10.1371/journal.pone.0204364. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30235340 (View on PubMed)

Other Identifiers

R.20.11.1099

Identifier Type: -

Identifier Source: org_study_id