Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: 3D mammography (Tomosynthesis); Device: Ultrasound

• Registration Number: NCT02066142
• Lead Sponsor: University of Genova

Brief Summary

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.

Aims

1. Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.

2. 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.

3. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

• Asymptomatic subjects <50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density 1-2 according to the Breast Imaging Reporting and Data System (BIRADS D1-2). - Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BIRADS 3-4.
• No history of breast cancer - Written informed consent

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Exclusion Criteria

• Pregnant and breast feeding women
• Unable to tolerate breast compression
• Breast implants
• Unable to understand or execute written informed consent
• Unable or unwilling to agree to follow-up during observation period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomosynthesis	3D mammography (Tomosynthesis)	Tomosynthesis will be compared to Ultrasound
Ultrasound	Ultrasound	Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis

Primary Outcome Measures

Name	Time	Method
1) Sensitivity of TS	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.

Secondary Outcome Measures

Name	Time	Method
2) Specificity of TS	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.

Trial Locations

Locations (1)

UNIGE; 🇮🇹 Genova, Italy