Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-29 @ 8:45 PM
Study NCT ID:
NCT01910103
Status:
COMPLETED
Last Update Posted:
2015-05-20
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.
Detailed Description:
1. Patients with dense breast will be examined for the detection of breast cancer by imaging studies.
2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.
2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: