Breast NeoplasmNCT04644848
Ultrasonographic Axillary Localization
A study testing Ultrasonographical tattooing of suspicious axillary lymph nodes., Sentinel lymph node biopsy and Histopathological examination of the axillary nodes in people with Breast Neoplasm, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Ultrasonographical tattooing of suspicious axillary lymph nodes., Sentinel lymph node biopsy and Histopathological examination of the axillary nodes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven invasive breast adenocarcinoma.
- Clinically non palpable axillary lymph nodes.
- T0-3, N0, M0
- Scheduled for definitive surgery.
Who cannot join
- Patient unwilling to participate.
- Contraindication to methylene blue technique: hypersensitivity, pregnancy.
- T4 primary tumor.
- Previous axillary surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Oncology Center
Al Mansurah, DK, 35516
Osama Hussein, MD,PhD,FEBS, +2010 9981 5110, osamahussein@mans.edu.eg
Eman Elnaghy
About this study
Official title: Diagnostic Accuracy of Preoperative Ultrasonographic Tattooing of Suspicious Axillary Lymph Nodes in Breast Cancer Patients With Clinically Negative Axilla. A Prospective Cohort Study.
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.
Read the 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.
- Conditions
- Breast Neoplasm
- Being tested
- Ultrasonographical tattooing of suspicious axillary lymph nodes., Sentinel lymph node biopsy, Histopathological examination of the axillary nodes, Further axillary management
- Keywords
- sentinel lymph node biopsy, Axillary ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sentinel lymph node biopsyProcedure or surgery
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 nodesDiagnostic 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 managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-sentinel node biopsy ultrasonographical tattooing | Experimental | Preoperative ultrasonographical tattooing of the suspicious lymph nodes. Sentinel Lymph Node Biopsy (SLNB), Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: at the date of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start15 Dec 2020
- Primary completionJan 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hussein, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644848
- Sponsor's protocol ID
- R.20.11.1099
- Status last verified
- Feb 2021
- First submitted
- 24 Nov 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28830644Li 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.
PubMed 30235340
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Preoperative Ultrasonographic Tattooing of Suspicious Axillary Lymph Nodes in Breast Cancer Patients With Clinically Negative Axilla. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04644848
- Acronym / sponsor ID
- R.20.11.1099
- Conditions
- Breast Neoplasm
- Keywords
- sentinel lymph node biopsy, Axillary ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-sentinel node biopsy ultrasonographical tattooing | Experimental | 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 managementPreoperative ultrasonographical tattooing of the suspicious lymph nodes. Sentinel Lymph Node Biopsy (SLNB), |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven invasive breast adenocarcinoma.
- Clinically non palpable axillary lymph nodes.
- T0-3, N0, M0
- Scheduled for definitive surgery.
Key exclusion criteria (4 listed)
- Patient unwilling to participate.
- Contraindication to methylene blue technique: hypersensitivity, pregnancy.
- T4 primary tumor.
- Previous axillary surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Pre-sentinel node biopsy ultrasonographical tattooing |
| Sentinel lymph node biopsySentinel 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. | Procedure or surgery | Pre-sentinel node biopsy ultrasonographical tattooing |
| Histopathological examination of the axillary nodesAll 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. | Diagnostic test | Pre-sentinel node biopsy ultrasonographical tattooing |
| Further axillary managementFurther 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. | Procedure or surgery | Pre-sentinel node biopsy ultrasonographical tattooing |
Primary outcome
Sensitivity of ultrasonographical tattooing
Time frame: at the date of surgery.
The ratio of the tattooed lymph nodes (that are positive by histopathological examination) to the sentinel lymph nodes (that are positive by histopathological examination).
Identification benefit of the ultrasonographical tattooing.
Time frame: at the date of surgery.
The ratio of the cases with successfully tattooed nodes and non identified sentinel node to the total number of analyzed cases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 28830644Kim 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.
- Background: PubMed 30235340Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographical tattooing of suspicious axillary lymph nodes., Sentinel lymph node biopsy and Histopathological examination of the axillary nodes in people with Breast Neoplasm, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Hussein, MD, PhD (+201099815110, osamahussein@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ultrasonographical tattooing (time frame: at the date of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644848, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.