Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer

NCT07591506 | Active Not Recruiting

• 1 other identifier: Breast
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.

Conditions

Breast Neoplasms

Keywords

sentinel lymph node biopsy; frozen section; breast cancer; intraoperative pathology; axillary staging

Outcome Measures

Primary Outcomes (1)

• Number of participants randomized to the frozen section group and the routine histopathology group

  Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants).

  From first participant enrollment until the target sample size is reached, up to 1 year

Secondary Outcomes (1)

• Percentage of participants in the routine histopathology group who require axillary lymph node dissection

  From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days

Study Arms (2)

Frozen Section Group

EXPERIMENTAL

Participants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results.

Diagnostic Test: Intraoperative Frozen Section Examination of Sentinel Lymph Node

Routine Histopathology Group

ACTIVE COMPARATOR

Participants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment.

Diagnostic Test: Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node

Interventions

Intraoperative Frozen Section Examination of Sentinel Lymph Node DIAGNOSTIC_TEST

Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.

Frozen Section Group

Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node DIAGNOSTIC_TEST

Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.

Routine Histopathology Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with breast carcinoma
• No prior neoadjuvant treatment

You may not qualify if:

• Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye
• Previous axillary surgery
• Recurrent breast cancer
• Patients who cannot receive radiotherapy
• Prior neoadjuvant treatment

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

SBÜ İzmir Şehir Hastanesi

Izmir, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Orhan Ureyen, Prof. / MD

  Izmir City Hospital / General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is applied. Surgeons and pathologists are aware of the intraoperative frozen section assessment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TU (1)