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Completed

NCT Number: NCT01963624

Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dongnam Inst. of Radiological and Medical Sciences, Busan, South Korea

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonography

Device

Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.

Other names: Aixplorer system (SuperSonic Imagine, France), EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)

Primary outcomes

  1. Positive predictive value of breast screening with US

    Time frame: 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 outcomes

  1. Sensitivity

    Time frame: 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.

  2. Specificity

    Time frame: 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.

  3. Diagnostic accuracy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2013
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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