Spots Global Cancer Trial Database for Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast
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Trial Identification
Brief Title: Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast
Official Title: Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast
Study ID: NCT02066142
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UNIGE, Genova, , Italy
Contact Details
Name: Alberto S Tagliafico, MD
Affiliation: UNIGE
Role: PRINCIPAL_INVESTIGATOR
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