NCT03130946

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
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.
DEVICE	FNA	FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2017-04-27
• Last updated: 2022-10-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study