Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast
NCT ID: NCT02066142
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
4000 participants
INTERVENTIONAL
2012-12-31
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tomosynthesis
Tomosynthesis will be compared to Ultrasound
3D mammography (Tomosynthesis)
Tomosynthesis will be used as normally employed in clinical practice
Ultrasound
Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis
Ultrasound
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3D mammography (Tomosynthesis)
Tomosynthesis will be used as normally employed in clinical practice
Ultrasound
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No history of breast cancer - Written informed consent
Exclusion Criteria
* 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
18 Years
90 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sydney
OTHER
University of Genova
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alberto Tagliafico
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alberto S Tagliafico, MD
Role: PRINCIPAL_INVESTIGATOR
UNIGE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UNIGE
Genova, Genova, Italy
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRA20132014
Identifier Type: -
Identifier Source: org_study_id