Clinical trial · Interventional
Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes
Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruiting rate.
Summary
Brief summary (as posted)
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.
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 |
|---|---|---|---|
| Cryo-assisted core needle biopsy | Device | — | UNRESOLVED |
| FNA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryo-assisted core needle biopsy
- description
- Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.
- interventionNames
- Device: Cryo-assisted core needle biopsy
- Device: FNA
- type
- ACTIVE_COMPARATOR
- label
- Fine needle aspiration alone
- description
- Patients undergo lymph node biopsy with FNA alone.
- interventionNames
- Device: FNA
Primary outcomes (1)
- measure
- Sensitivity of biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer. * With axillary lymph node with thickened cortex. * Planned for sentinel lymph node biopsy or axillary clearance. Exclusion Criteria: * Nodes ultrasonographically normal. * Nodes with hilar displacement . * Palpable matted nodes.
References
Publications (0)
Data not yet available