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

November 30, 2015 updated by: Alberto Tagliafico, University of Genova

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • Unige

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tomosynthesis
Tomosynthesis will be compared to Ultrasound
Device: 3D mammography (Tomosynthesis)
Tomosynthesis will be used as normally employed in clinical practice
Other: Ultrasound
Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis
Device: Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Collaborators

University of Sydney

Investigators

  • Principal Investigator: Alberto S Tagliafico, MD, Unige

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PRA20132014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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