Breast CarcinomaNCT07338721
Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?
An observational study of Breast Carcinoma and Sentinel Lymph Node Biopsy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center randomized controlled trial evaluates whether detecting the first lymph node at the axillary entrance with ultrasound guidance, followed by a targeted axillary incision over the pencil-marked projection, improves sentinel lymph node identification compared to the conventional axillary hairline… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Sentinel Lymph Node Biopsy
- What is being tested?
- Ultrasound-guided axillary incision group and The standard axillary incision
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Sep 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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
Study population: Patients scheduled for sentinel lymph node biopsy due to breast cancer at Antalya Training and Research Hospital.
Who may be able to join
- * Patients with clinical stage T1-T3 disease (tumor ≤5 cm), pN0-pN1 (one to three regional lymph nodes with micrometastases or metastases), and M0 (no distant metastasis) are eligible. Post-neoadjuvant yT1-T3, yN0-yN1, and M0 status are also eligible. All patients are undergoing axillary staging.
- Clinically negative axilla
- Written informed consent must be obtained prior to inclusio
Who cannot join
- Younger than 18 years
- Previous breast malignancy
- Pregnancy
- Pre-operative diagnosis of axillary lymph node metastases
- The presence of multiple clinically involved or suspicious lymph nodes
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, 07100
About this study
Official title: Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?
This single-center randomized controlled trial evaluates whether detecting the first lymph node at the axillary entrance with ultrasound guidance, followed by a targeted axillary incision over the pencil-marked projection, improves sentinel lymph node identification compared to the conventional axillary hairline landmark. The study hypothesizes that this technique enables a smaller incision, minimizes tissue dissection, and reduces operative time.
Read the detailed description
Axillary lymph node status is a key prognostic factor in breast cancer treatment planning. Accurate axillary staging is essential for optimal management. Sentinel lymph node biopsy (SLNB) provides reliable nodal assessment and is associated with lower morbidity relative to axillary dissection. The sentinel lymph node is the initial recipient of lymphatic drainage from the primary tumor, and breast lymphatics typically drain into at least one sentinel node.
The majority of sentinel nodes are located in level I, particularly within the anterior axillary (pectoral) lymph nodes. These nodes are positioned at the inferolateral border of the pectoralis minor muscle, adjacent to the lateral thoracic vessels, and are typically in contact with the axillary tail of the breast.
The standard axillary incision for SLNB is performed parallel to the Langer line, below the axillary hairline. Blue-stained lymph nodes are identified and excised by following the blue-stained lymphatic channels.
The anterior axillary (pectoral) lymph node can be identified by placing the ultrasound transducer on the flattened lateral breast and axillary tail after appropriate patient positioning. Ultrasound guidance during an axillary incision at the projection of this lymph node allows direct access to the blue-stained sentinel lymph node. This approach reduces the extent of dissection and the need for channel tracking compared to the standard technique, resulting in a smaller incision, less tissue dissection, and shorter operative time.
This study evaluates whether ultrasound-guided projection of the first lymph node at the axillary entry during an axillary incision, followed by tracing the blue-stained lymphatic channel and identifying adjacent lymph nodes, reduces operative time and morbidity by minimizing dissection compared to the standard axillary hairline landmark approach.
- Conditions
- Breast Carcinoma, Sentinel Lymph Node Biopsy
- Being tested
- Ultrasound-guided axillary incision group, The standard axillary incision
- Keywords
- Breast cancer, Axilla, Sentinel Lymph Node Biopsy, 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.
Ultrasound-guided axillary incision groupProcedure or surgery
In the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry.
The standard axillary incisionProcedure or surgery
In the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline.
| Study group | Role | What they receive |
|---|---|---|
| The ultrasound-guided axillary incision group. | In the ultrasound-guided axillary incision group, the incision is made parallel to the Langer lines under ultrasound guidance, targeting the projection of the first lymph node at the axillary entry. Receives: Procedure: Ultrasound-guided axillary incision group | |
| The standard hairline axillary incision group | In the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry. Receives: Procedure: The standard axillary incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative assessment of surgical performance parameters.
Measurements will include incision details and lymph node detection times.
Measured: Until completion of the sentinel lymph node procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Baris Karakas, Antalya Training and Research Hospital
- Investigators
- Baris R KARAKAS, Assoc. Prof., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338721
- Sponsor's protocol ID
- AEAH-GS-BRK-01
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fenech M, Burke T, Arnett G, Tanner A, Werder N. Sonographic localisation of lymph nodes suspicious of metastatic breast cancer to surgical axillary levels. J Med Radiat Sci. 2025 Mar;72(1):119-138. doi: 10.1002/jmrs.840. Epub 2024 Nov 17.
PubMed 39552171Suami H, Pan WR, Mann GB, Taylor GI. The lymphatic anatomy of the breast and its implications for sentinel lymph node biopsy: a human cadaver study. Ann Surg Oncol. 2008 Mar;15(3):863-71. doi: 10.1245/s10434-007-9709-9. Epub 2007 Nov 28.
PubMed 18043970Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759.
PubMed 37733364Veronesi U, Paganelli G, Galimberti V, Viale G, Zurrida S, Bedoni M, Costa A, de Cicco C, Geraghty JG, Luini A, Sacchini V, Veronesi P. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet. 1997 Jun 28;349(9069):1864-7. doi: 10.1016/S0140-6736(97)01004-0.
PubMed 9217757Tanis PJ, Nieweg OE, Valdes Olmos RA, Kroon BB. Anatomy and physiology of lymphatic drainage of the breast from the perspective of sentinel node biopsy. J Am Coll Surg. 2001 Mar;192(3):399-409. doi: 10.1016/s1072-7515(00)00776-6.
PubMed 11245383
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?
- ClinicalTrials.gov ID
- NCT07338721
- Acronym / sponsor ID
- AEAH-GS-BRK-01
- Conditions
- Breast Carcinoma, Sentinel Lymph Node Biopsy
- Keywords
- Breast cancer, Axilla, Sentinel Lymph Node Biopsy, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 14 Jan 2026 (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.
This single-center randomized controlled trial evaluates whether detecting the first lymph node at the axillary entrance with ultrasound guidance, followed by a targeted axillary incision over the pencil-marked projection, improves sentinel lymph node identification compared to the conventional axillary hairline landmark. The study hypothesizes that this technique enables a smaller incision, minimizes tissue dissection, and reduces operative time.
Detailed description
Axillary lymph node status is a key prognostic factor in breast cancer treatment planning. Accurate axillary staging is essential for optimal management. Sentinel lymph node biopsy (SLNB) provides reliable nodal assessment and is associated with lower morbidity relative to axillary dissection. The sentinel lymph node is the initial recipient of lymphatic drainage from the primary tumor, and breast lymphatics typically drain into at least one sentinel node.
The majority of sentinel nodes are located in level I, particularly within the anterior axillary (pectoral) lymph nodes. These nodes are positioned at the inferolateral border of the pectoralis minor muscle, adjacent to the lateral thoracic vessels, and are typically in contact with the axillary tail of the breast.
The standard axillary incision for SLNB is performed parallel to the Langer line, below the axillary hairline. Blue-stained lymph nodes are identified and excised by following the blue-stained lymphatic channels.
The anterior axillary (pectoral) lymph node can be identified by placing the ultrasound transducer on the flattened lateral breast and axillary tail after appropriate patient positioning. Ultrasound guidance during an axillary incision at the projection of this lymph node allows direct access to the blue-stained sentinel lymph node. This approach reduces the extent of dissection and the need for channel tracking compared to the standard technique, resulting in a smaller incision, less tissue dissection, and shorter operative time.
This study evaluates whether ultrasound-guided projection of the first lymph node at the axillary entry during an axillary incision, followed by tracing the blue-stained lymphatic channel and identifying adjacent lymph nodes, reduces operative time and morbidity by minimizing dissection compared to the standard axillary hairline landmark approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ultrasound-guided axillary incision group. | – | Procedure: Ultrasound-guided axillary incision groupIn the ultrasound-guided axillary incision group, the incision is made parallel to the Langer lines under ultrasound guidance, targeting the projection of the first lymph node at the axillary entry. |
| The standard hairline axillary incision group | – | Procedure: The standard axillary incisionIn the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for sentinel lymph node biopsy due to breast cancer at Antalya Training and Research Hospital.
Key inclusion criteria (3 listed)
- * Patients with clinical stage T1-T3 disease (tumor ≤5 cm), pN0-pN1 (one to three regional lymph nodes with micrometastases or metastases), and M0 (no distant metastasis) are eligible. Post-neoadjuvant yT1-T3, yN0-yN1, and M0 status are also eligible. All patients are undergoing axillary staging.
- Clinically negative axilla
- Written informed consent must be obtained prior to inclusio
Key exclusion criteria (6 listed)
- Younger than 18 years
- Previous breast malignancy
- Pregnancy
- Pre-operative diagnosis of axillary lymph node metastases
- The presence of multiple clinically involved or suspicious lymph nodes
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 |
|---|---|---|
| Ultrasound-guided axillary incision groupIn the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry. | Procedure or surgery | The ultrasound-guided axillary incision group. |
| The standard axillary incisionIn the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline. | Procedure or surgery | The standard hairline axillary incision group |
Primary outcome
Intraoperative assessment of surgical performance parameters.
Time frame: Until completion of the sentinel lymph node procedure
Measurements will include incision details and lymph node detection times.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 39552171Fenech M, Burke T, Arnett G, Tanner A, Werder N. Sonographic localisation of lymph nodes suspicious of metastatic breast cancer to surgical axillary levels. J Med Radiat Sci. 2025 Mar;72(1):119-138. doi: 10.1002/jmrs.840. Epub 2024 Nov 17.
- Background: PubMed 18043970Suami H, Pan WR, Mann GB, Taylor GI. The lymphatic anatomy of the breast and its implications for sentinel lymph node biopsy: a human cadaver study. Ann Surg Oncol. 2008 Mar;15(3):863-71. doi: 10.1245/s10434-007-9709-9. Epub 2007 Nov 28.
- Background: PubMed 37733364Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. Sentinel Lymph Node Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759.
- Background: PubMed 9217757Veronesi U, Paganelli G, Galimberti V, Viale G, Zurrida S, Bedoni M, Costa A, de Cicco C, Geraghty JG, Luini A, Sacchini V, Veronesi P. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet. 1997 Jun 28;349(9069):1864-7. doi: 10.1016/S0140-6736(97)01004-0.
- Background: PubMed 11245383Tanis PJ, Nieweg OE, Valdes Olmos RA, Kroon BB. Anatomy and physiology of lymphatic drainage of the breast from the perspective of sentinel node biopsy. J Am Coll Surg. 2001 Mar;192(3):399-409. doi: 10.1016/s1072-7515(00)00776-6.
- Individual participant dataSharing planned: No
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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.
Baris R KARAKAS, Assoc. Prof. principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Sentinel Lymph Node Biopsy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative assessment of surgical performance parameters. (time frame: Until completion of the sentinel lymph node procedure). 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 NCT07338721, which also lists 5 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 21 Sep 2026.