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

NCT02066142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2015-12-02

No results posted yet for this study

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

Interventions

DEVICE

3D mammography (Tomosynthesis)

Tomosynthesis will be used as normally employed in clinical practice

DEVICE

Ultrasound

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • University of Genova

    lead OTHER

Principal Investigators

  • Alberto S Tagliafico, MD · UNIGE

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066142 on ClinicalTrials.gov