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

Breast Cancer Clinical Trial

— ASTOUND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066142
• Other study ID #: PRA20132014
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2014
• Last updated: November 30, 2015
• Start date: December 2012
• Est. completion date: July 2018

Study information

• Verified date: November 2015
• Source: University of Genova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 3D mammography (Tomosynthesis)
Tomosynthesis will be used as normally employed in clinical practice
• Ultrasound

Locations

Country	Name	City	State
Italy	UNIGE	Genova

Sponsors (2)

Lead Sponsor	Collaborator
University of Genova	University of Sydney

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) Sensitivity of TS	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	No
Secondary	2) Specificity of TS	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	No