Ultrasonographic Axillary Localization

NCT04644848 | Unknown

• 1 other identifier: R.20.11.1099
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Keywords

sentinel lymph node biopsy; Axillary ultrasonography

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ultrasonographical tattooing

  The ratio of the tattooed lymph nodes (that are positive by histopathological examination) to the sentinel lymph nodes (that are positive by histopathological examination).

  at the date of surgery.

• Identification benefit of the ultrasonographical tattooing.

  The ratio of the cases with successfully tattooed nodes and non identified sentinel node to the total number of analyzed cases.

  at the date of surgery.

Other Outcomes (2)

• Negative predictive value of ultrasonographical tattooing.

  at the date of surgery.

• Concordance of ultrasonographical tattooing with sentinel lymph nodes.

  at the date of surgery.

Study Arms (1)

Pre-sentinel node biopsy ultrasonographical tattooing

EXPERIMENTAL

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

Diagnostic Test: Ultrasonographical tattooing of suspicious axillary lymph nodes.; Procedure: Sentinel lymph node biopsy; Diagnostic Test: Histopathological examination of the axillary nodes; Procedure: Further axillary management

Interventions

Ultrasonographical tattooing of suspicious axillary lymph nodes. 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.

Pre-sentinel node biopsy ultrasonographical tattooing

Sentinel lymph node biopsy 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.

Pre-sentinel node biopsy ultrasonographical tattooing

Histopathological examination of the axillary nodes 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.

Pre-sentinel node biopsy ultrasonographical tattooing

Further axillary management 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.

Pre-sentinel node biopsy ultrasonographical tattooing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Oncology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 28830644 BACKGROUND

• 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.

  PMID: 30235340 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Central Study Contacts

Osama Hussein, MD, PhD

CONTACT

+201099815110; osamahussein@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 25, 2020
• Study Start: December 15, 2020
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

EG (1)