Ultrasonographic Axillary Localization
Diagnostic Accuracy of Preoperative Ultrasonographic Tattooing of Suspicious Axillary Lymph Nodes in Breast Cancer Patients With Clinically Negative Axilla. A Prospective Cohort Study.
Study Overview
Status
Conditions
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
- Determination of the diagnostic accuracy of preoperative ultrasonic guided tattooing of suspicious axillary lymph nodes.
- Determination of node-to-node concordance of ultrasonographic tattooing relative to blue dye SLNB.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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DK
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Mansourah, DK, Egypt, 35516
- Recruiting
- Mansoura University Oncology Center
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Contact:
- Osama Hussein, MD,PhD,FEBS
- Phone Number: +2010 9981 5110
- Email: osamahussein@mans.edu.eg
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Sub-Investigator:
- Eman Elnaghy
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Sub-Investigator:
- Mai Ali
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Sub-Investigator:
- Khadija Ali
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pre-sentinel node biopsy ultrasonographical tattooing
Preoperative ultrasonographical tattooing of the suspicious lymph nodes.
Sentinel Lymph Node Biopsy (SLNB),
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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:
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 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.
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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity of ultrasonographical tattooing
Time Frame: at the date of surgery.
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The ratio of the tattooed lymph nodes (that are positive by histopathological examination) to the sentinel lymph nodes (that are positive by histopathological examination).
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at the date of surgery.
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Identification benefit of the ultrasonographical tattooing.
Time Frame: at the date of surgery.
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The ratio of the cases with successfully tattooed nodes and non identified sentinel node to the total number of analyzed cases.
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at the date of surgery.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Negative predictive value of ultrasonographical tattooing.
Time Frame: at the date of surgery.
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The ratio of tattooed nodes (that are negative by histopathological examination) to the sentinel lymph nodes (that are negative by histopathological examination).
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at the date of surgery.
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Concordance of ultrasonographical tattooing with sentinel lymph nodes.
Time Frame: at the date of surgery.
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The ratio of cases that have similar histopathological examination results (of both tattooed and sentinel nodes) to the total number of analyzed cases.
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at the date of surgery.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.20.11.1099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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