Accuracy of VABB Elite 10G Versus BARD 14G CNB

Accuracy of Vacuum-assisted Breast Biopsy Elite 10G Versus BARD 14G Core Needle Biopsy of Abnormal Breast Lesions.

In this study, patients whose breast ultrasound showed a space-occupying lesion and needed biopsy to clarify the pathology were selected as the research subjects. This study aims to determine whether Vacuum-assisted biopsy device Elite is superior to the traditional BARD ejection type air core needle in the diagnosis of breast cancer through a prospective randomized study.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: VABB Elite 10G; Device: BARD 14G CNB

Detailed Description

The main purpose of the study was to analyze the difference in the accuracy of two biopsy devices in the diagnosis of breast cancer puncture. The purpose of the secondary study was to analyze the difference between the underestimation rate, false negative rate, sensitivity, and negative predictive value of the two devices, the consistency of the immunohistochemistry between the puncture pathology and surgical pathology of the two groups of patients, the number and time-consuming of the puncture acquisition specimens, and the two biopsies Differences in the incidence of complications (safety).

If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material.

• Study Type: Interventional
• Enrollment (Anticipated): 1470
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over 18 years old (including 18 years old)
• Ultrasound examination indicates the presence of space-occupying lesions in the breast. The size, location, and BI-RADS classification are not limited.
• Agree to undergo surgery after puncture
• Ability and willingness to sign informed consent

Exclusion Criteria:

• A biopsy has been performed in the external hospital
• Contraindications for puncture or surgery such as severe coagulation dysfunction
• Refuse breast surgery
• Axillary lymph node puncture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VABB Elite 10G; Vacuum-assisted Elite 10G	Device: VABB Elite 10G; If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle
Active Comparator: BARD 14G CNB; BARD 14G Core needle	Device: BARD 14G CNB; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	The accuracy of the puncture pathology was defined as the proportion of patients in the study population who were consistent with the qualitative diagnosis of the puncture pathology and surgical pathology.When the pathological diagnosis of puncture is "carcinoma in situ of the catheter", if the pathological diagnosis of the catheter is "carcinoma in situ of the catheter with microinfiltration", the puncture is considered accurate;If the surgical pathology confirms "invasive cancer (infiltrating lesion >1mm)", the pathology of the puncture is considered inaccurate (ie, underestimated)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of immunohistochemical marker status	ER,PR, HER2and Ki67from tissues obtained by percutaneous biopsy and follow on surgical procedure.	3 months
Sensitivity	The proportion of patients with abreast cancer diagnosis by percutaneous biopsy among all patients receiving an invasive breast cancer diagnosis by either percutaneous biopsy or by follow on surgical procedure.	3 months
Negative Prediction Value	The proportion of patients whose diagnosis from percutaneous biopsy is benign, among all patients with a benign diagnosis by follow on surgical procedure, ORthe proportion of patients whose diagnosis from percutaneous biopsy is benign, among all patients whose malignant lesions were not diagnosed within less than 1 year of follow-up after initial percutaneous biopsy.	3 months
Underestimation Rate	The rate at which the surgical procedure following a percutaneous biopsy upgrades or upstages the severity of histopathologic diagnosis. For example, a) if percutaneous biopsy indicated benign lesions, and the subsequent surgical procedureidentifiedprecancerous lesions (e.g., ADH) or malignant lesions (DCIS or invasive adenocarcinoma); or b) if percutaneous biopsy indicated precancerous lesions, and follow up surgical procedureidentified malignant lesions(DCIS or invasive adenocarcinoma); or 3) if percutaneous biopsyindicated carcinoma in situ,and follow up surgical procedure identified infiltrating carcinoma (except microinvasive foci <1mm) identified by follow onsurgical procedure.	3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Rate of immediate bleeding on the day of puncture (bleeding requiring a compression bandage); rate of bleeding that cannot be stopped by a compression bandage within 48 hours after procedure; rate of hematoma on the second day after puncture; rate of skin ecchymosis and puncture point infection (local redness, swelling, heat and pain).	7 days

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Junjie Li, MD, Fudan University; Principal Investigator: Ying Zhang, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2008222-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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