Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?

NCT07338721 | Recruiting

• 1 other identifier: AEAH-GS-BRK-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 landmark. The study hypothesizes that this technique enables a smaller incision, minimizes tissue dissection, and reduces operative time.

Conditions

Breast Carcinoma; Sentinel Lymph Node Biopsy

Keywords

Breast cancer; Axilla; Sentinel Lymph Node Biopsy; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Intraoperative assessment of surgical performance parameters.

  Measurements will include incision details and lymph node detection times.

  Until completion of the sentinel lymph node procedure

Study Arms (2)

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.

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.

Procedure: The standard axillary incision

Interventions

Ultrasound-guided axillary incision group PROCEDURE

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 ultrasound-guided axillary incision group.

The standard axillary incision PROCEDURE

In the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline.

The standard hairline axillary incision group

Eligibility Criteria

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

Study Population

Patients scheduled for sentinel lymph node biopsy due to breast cancer at Antalya Training and Research Hospital.

You may qualify if:

• \* 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 39552171 BACKGROUND

• Suami 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.

  PMID: 18043970 BACKGROUND

• Gentilini 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.

  PMID: 37733364 BACKGROUND

• Veronesi 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.

  PMID: 9217757 BACKGROUND

• Tanis 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.

  PMID: 11245383 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Baris R KARAKAS, Assoc. Prof.

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)