Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01963624
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

Detailed Description

* Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.

* The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.

* Reference standard: Biopsy or 1 year of follow-up examination.

* The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.

Study Timeline

• Study First Submitted: 2013-10-13
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-16
• Study Start: 2013-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1241

Inclusion Criteria

• Women aged 30 years or older screened with breast ultrasound without specific symptoms
• Women who underwent mammography within 3 months which showed no abnormality except for dense breast
• Women who had at least one breast mass of BI-RADS category 3 or higher.

Exclusion Criteria

• Women with breast implants
• Women who are unwilling or unable to provide informed consent
• Lesions larger than 3 cm
• Lesions that are previously noted and followed-up in the same hospital

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive predictive value of breast screening with US	1 year after enrollment	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Secondary Outcome Measures

Name	Time	Method
Sensitivity	1 year after enrollment	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Specificity	1 year after enrollment	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
Diagnostic accuracy	1 year after enrollment	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Trial Locations

Locations (10)

Dongnam Inst. of Radiological and Medical Sciences; 🇰🇷 Busan, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

CHA Bundang Medical Center, School of Medicine, CHA University; 🇰🇷 Seongnam-si, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of

Seoul Metroplitan Government-Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital Healthcare System Gangnam Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of