Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Breast Cancer Clinical Trial

Official title:

Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963624
• Other study ID #: Elasto-Doppler Ultrasonography
• Status: Completed
• Phase: N/A
• First received: October 13, 2013
• Last updated: April 18, 2016
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1241
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Ultrasonography
Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.

Locations

Country	Name	City	State
Korea, Republic of	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	Seoul
Korea, Republic of	Seoul National University Hospital Healthcare System Gangnam Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive value of breast screening with US	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.	1 year after enrollment	No
Secondary	Sensitivity	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.	1 year after enrollment	No
Secondary	Specificity	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.	1 year after enrollment	No
Secondary	Diagnostic accuracy	Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.	1 year after enrollment	No