NCT04612439

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,470

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

September 14, 2020

Last Update Submit

September 10, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Concordance of immunohistochemical marker status

    3 months

  • Sensitivity

    3 months

  • Negative Prediction Value

    3 months

  • Underestimation Rate

    3 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    7 days

Study Arms (2)

VABB Elite 10G

EXPERIMENTAL

Vacuum-assisted Elite 10G

Device: VABB Elite 10G

BARD 14G CNB

ACTIVE COMPARATOR

BARD 14G Core needle

Device: BARD 14G CNB

Interventions

VABB Elite 10GDEVICE

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

VABB Elite 10G
BARD 14G CNBDEVICE

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

BARD 14G CNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

  • Zhang Y, Li J, Mo M, Shen J, Ren H, Li S, Liu G, Shao Z. The comparison of efficacy and safety evaluation of vacuum-assisted Elite 10-G system and the traditional BARD 14-G core needle in breast diagnosis: an open-label, parallel, randomized controlled trial. Int J Surg. 2023 May 1;109(5):1180-1187. doi: 10.1097/JS9.0000000000000257.

    PMID: 37042316DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Junjie Li, MD

    Fudan University

    STUDY DIRECTOR

  • Ying Zhang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

November 3, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)