Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03130946
• Other study ID #: Axbiopsy
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 135
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• Cryo-assisted core needle biopsy
Rotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis.
• FNA
FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of biopsy	True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA	Immediate after pathological lymph node stage is available
Secondary	Specificity	The true negative rate measures the proportion of negatives that are correctly identified.	Immediate after pathological lymph node stage is available.
Secondary	Sample adequency	The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists	Immediate after biopsy specimen is evaluated by pathologists.
Secondary	Adverse effect of surgery	Hematoma, bleeding need , suture exposure and extrusion.	4 weeks after surgery.