Clinical trial · Interventional
Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer
Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer: A Prospective Randomized Clinical Study
NCT07591506CI-TRIAL-00111664active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Frozen Section Examination of Sentinel Lymph Node | Diagnostic Test | — | UNRESOLVED |
| Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Frozen Section Group
- description
- 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.
- interventionNames
- Diagnostic Test: Intraoperative Frozen Section Examination of Sentinel Lymph Node
- type
- ACTIVE_COMPARATOR
- label
- Routine Histopathology Group
- description
- 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.
- interventionNames
- Diagnostic Test: Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with breast carcinoma * No prior neoadjuvant treatment Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.