Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

NCT03130946 | Suspended FDA Device

• 1 other identifier: Axbiopsy
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

breast neoplasms; Ultrasonography, Interventional; Biopsy, Large-Core Needle; Biopsy, Fine-Needle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity

  Immediate after pathological lymph node stage is available.

• Sample adequency

  Immediate after biopsy specimen is evaluated by pathologists.

• Adverse effect of surgery

  4 weeks after surgery.

Study Arms (2)

Cryo-assisted core needle biopsy

EXPERIMENTAL

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

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

Fine needle aspiration alone

ACTIVE COMPARATOR

Patients undergo lymph node biopsy with FNA alone.

Device: FNA

Interventions

Cryo-assisted core needle biopsy DEVICE

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.

Cryo-assisted core needle biopsy

FNA DEVICE

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

Cryo-assisted core needle biopsy; Fine needle aspiration alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive breast cancer.
• With axillary lymph node with thickened cortex.
• Planned for sentinel lymph node biopsy or axillary clearance.

You may not qualify if:

• Nodes ultrasonographically normal.
• Nodes with hilar displacement .
• Palpable matted nodes.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 10044, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shu Wang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arm, prospective, open label study

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 27, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

CN (1)