Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Peking University

Status: Suspended

Conditions: Breast Neoplasms

Treatments: Device: FNA; Device: Cryo-assisted core needle biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03130946

Axbiopsy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Cryo-assisted core needle biopsy

Experimental group

Description:

Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.

Treatment:

Device: FNA

Device: Cryo-assisted core needle biopsy

Fine needle aspiration alone

Active Comparator group

Description:

Patients undergo lymph node biopsy with FNA alone.

Treatment:

Device: FNA