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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02066142
Recruitment Status : Unknown
Verified November 2015 by Alberto Tagliafico, University of Genova.
Recruitment status was:  Recruiting
First Posted : February 19, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Alberto Tagliafico, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: 3D mammography (Tomosynthesis) Device: Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast
Study Start Date : December 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

Ultrasound
Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis
Device: Ultrasound



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066142


Locations
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Italy
UNIGE Recruiting
Genova, Italy, 16132
Contact: Alberto S Tagliafico, MD    +390103637873    alberto.tagliafico@unige.it   
Principal Investigator: Alberto S Tagliafico, MD         
Sponsors and Collaborators
University of Genova
University of Sydney
Investigators
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Principal Investigator: Alberto S Tagliafico, MD UNIGE

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Responsible Party: Alberto Tagliafico, Assistant Professor, University of Genova
ClinicalTrials.gov Identifier: NCT02066142    
Other Study ID Numbers: PRA20132014
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015