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

NCT02066142 | Unknown

• 1 other identifier: PRA20132014
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 2) Specificity of TS

  up to 36 months

Study Arms (2)

Tomosynthesis

ACTIVE COMPARATOR

Tomosynthesis will be compared to Ultrasound

Device: 3D mammography (Tomosynthesis)

Ultrasound

OTHER

Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis

Device: Ultrasound

Interventions

3D mammography (Tomosynthesis) DEVICE

Tomosynthesis will be used as normally employed in clinical practice

Tomosynthesis

Ultrasound DEVICE

Ultrasound

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead
• University of Sydney: collaborator

Study Sites (1)

UNIGE

Genova, Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography; Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alberto S Tagliafico, MD

  UNIGE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 19, 2014
• Study Start: December 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

IT (1)