Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast (ASTOUND)
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|ClinicalTrials.gov Identifier: NCT02066142|
Recruitment Status : Unknown
Verified November 2015 by Alberto Tagliafico, University of Genova.
Recruitment status was: Recruiting
First Posted : February 19, 2014
Last Update Posted : December 2, 2015
Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference between TS and US in women with dense breast screened negative at 2D Mammography.
If the equivalence between TS and US will be demonstrated, US may be substituted by TS with great benefits for the patients and for the healthcare resources.
- Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
- If TS detects new cancers in dense breast similarly to US (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio.
- Cost-analysis. In case of less false positives detected by TS, the true-positive / false positive trade-off might be strongly in favour of TS with a great potential of costs reduction.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: 3D mammography (Tomosynthesis) Device: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Tomosynthesis
Tomosynthesis will be compared to Ultrasound
Device: 3D mammography (Tomosynthesis)
Tomosynthesis will be used as normally employed in clinical practice
Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis
- 1) Sensitivity of TS [ Time Frame: up to 36 months ]We want to verify if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
- 2) Specificity of TS [ Time Frame: up to 36 months ]If TS detects new cancers in dense breast similarly to US (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066142
|Genova, Italy, 16132|
|Contact: Alberto S Tagliafico, MD +390103637873 firstname.lastname@example.org|
|Principal Investigator: Alberto S Tagliafico, MD|
|Principal Investigator:||Alberto S Tagliafico, MD||UNIGE|