NCT02066142

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: University of Genova · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	3D mammography (Tomosynthesis)	Tomosynthesis will be used as normally employed in clinical practice
DEVICE	Ultrasound

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-02-19
• Last updated: 2015-12-02

Locations

1 site across 1 country: Italy