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Breast CancerPhase 3NCT04612439

Accuracy of VABB Elite 10G Versus BARD 14G CNB

A Phase 3 study testing VABB Elite 10G and BARD 14G CNB in people with Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
VABB Elite 10G and BARD 14G CNB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,470 participants
Where
1 siteChina
Study dates
1 Nov 2020to 30 Jun 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
VABB Elite 10G, BARD 14G CNB
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT04612439
Study groupRoleWhat they receive
VABB Elite 10GExperimentalVacuum-assisted Elite 10G
Receives: Device: VABB Elite 10G
BARD 14G CNBActive comparatorBARD 14G Core needle
Receives: Device: BARD 14G CNB

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (5)

  1. Concordance of immunohistochemical marker status

    ER,PR, HER2and Ki67from tissues obtained by percutaneous biopsy and follow on surgical procedure.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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).

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,470 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04612439
Sponsor's protocol ID
2008222-12
Status last verified
Sep 2021
First submitted
14 Sep 2020
Last updated
14 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37042316

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VABB Elite 10G and BARD 14G CNB in people with Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04612439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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