Stereotactic Directional Vacuum-Assisted Breast Biopsy

Breast Cancer Clinical Trial

Official title:

The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957020
• Other study ID #: 200806017R
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: October 13, 2013
• Start date: June 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 years ( July 2008 to June 2013)	No