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

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.

Study Overview

• Status: Suspended
• Conditions: Breast Neoplasms
• Intervention / Treatment: Device: Cryo-assisted core needle biopsy; Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cryo-assisted core needle biopsy; Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.	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.
ACTIVE_COMPARATOR: Fine needle aspiration alone; Patients undergo lymph node biopsy with FNA alone.	Device: FNA; FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	The true negative rate measures the proportion of negatives that are correctly identified.	Immediate after pathological lymph node stage is available.
Sample adequency	The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists	Immediate after biopsy specimen is evaluated by pathologists.
Adverse effect of surgery	Hematoma, bleeding need , suture exposure and extrusion.	4 weeks after surgery.

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasonography, Interventional; breast neoplasms; Biopsy, Fine-Needle; Biopsy, Large-Core Needle
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Axbiopsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes