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CompletedNCT01957020Updated Oct 16, 2013

Stereotactic Directional Vacuum-Assisted Breast Biopsy

An observational study in Breast Cancer, Stereotactic Directional Vacuum-assisted Breast Biopsy and Female, sponsored by National Taiwan University Hospital. Completed. Open to female participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-16.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
130
Ages
30 Years to 80 Years
Sex
Female
01

Study summary

Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy [6,7]. However, its sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.

02

Conditions studied

  • Breast Cancer
  • Stereotactic Directional Vacuum-assisted Breast Biopsy
  • Female
  • Adult Patients
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

asymptomatic women with mammographic screening, and with suspicious findings on mammography.

Inclusion criteria

  • The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
130 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis

    the aforementioned outcome measure-"sensitivity"- is the probability of the stereotactic vaccum assisted breast biopsy can correctly diagnose the breast cancer. And according to statistical definition, it is defined as- for those breast cancer cases, how many of them can be correctly diagnosed by stereotactic breast biopsy.

    Time frame: up to 5 years ( July 2008 to June 2013)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01957020
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Oct 8, 2013
Start date
Jun 2008
Primary completion
Dec 2008
Completion
Jan 2009
Last update
Oct 16, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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