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Ultrasound-Guided Cable-Free 13-Gauge Vacuum-Assisted Biopsy of Non-Mass Breast Lesions

Evaluation of the usefulness of 13G vacuum-assisted breast biopsy in suspicious breast disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0002267
Enrollment
125
Registered
2017-03-16
Start date
2013-08-27
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : All biopsies were performed after the patient received a description of the risks and benefits and provided written consent. One of the three breast radiologists received two types of
s preference.

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Among those who were diagnosed with nonmass breast lesion which detected on ultrasound and classified as BI-RADS category 4 or 5 and those who agreed to participate in the study. The inclusion criteria for breast nonmass lesions were as follows: Non mass lesions classified as BI-RADS category 4 or 5 with suspicious microcalcifications on US that correlated with a lesion previously detected via mammography, or US-correlated lesion detected via breast MRI.

Exclusion criteria

Exclusion criteria: The exclusion criteria were a lack of available follow-up images of benign confirmed lesions and a lack of available surgical pathologic results of confirmed malignancies or high-risk lesions.

Design outcomes

Primary

MeasureTime frame
Success rate of each biopsy test

Secondary

MeasureTime frame
Hidtologic underestimation

Countries

Korea, Republic of

Contacts

Public ContactSun Mi Kim

Seoul National University Bundang Hospital

kimsmlms@daum.net+82-31-787-7609

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 26, 2026