Breast CancerASTOUNDNCT02066142
Tomosynthesis (TS) Versus Ultrasonography (US) in Women With Dense Breast
A study testing 3D mammography (Tomosynthesis) and Ultrasound in people with Breast Cancer, run by University of Genova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3D mammography (Tomosynthesis) and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UNIGE
Genova, Genova, 16132
Alberto S Tagliafico, MD, +390103637873, alberto.tagliafico@unige.it
Alberto S Tagliafico, MD
About this study
Official title: 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.
Read more
Aims
- Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
- 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.
- 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
- Being tested
- 3D mammography (Tomosynthesis), Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D mammography (Tomosynthesis)Device
Tomosynthesis will be used as normally employed in clinical practice
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis | Active comparator | Tomosynthesis will be compared to Ultrasound Receives: Device: 3D mammography (Tomosynthesis) |
| Ultrasound | Other | Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 months
Secondary outcomes (1)
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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startDec 2012
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Alberto Tagliafico, University of Genova
- Investigators
- Alberto S Tagliafico, MD, Principal investigator, UNIGE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066142
- Sponsor's protocol ID
- PRA20132014
- Acronym
- ASTOUND
- Status last verified
- Nov 2015
- First submitted
- 10 Feb 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast
- ClinicalTrials.gov ID
- NCT02066142
- Acronym / sponsor ID
- ASTOUND / PRA20132014
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Dec 2012
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis | Active comparator | Device: 3D mammography (Tomosynthesis)Tomosynthesis will be compared to Ultrasound |
| Ultrasound | Other | Device: UltrasoundUltrasound (sensitivity and specificity) will be compared to Tomosynthesis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D mammography (Tomosynthesis)Tomosynthesis will be used as normally employed in clinical practice | Device | Tomosynthesis |
| Ultrasound | Device | Ultrasound |
Primary outcome
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.
1 secondary outcome
2) Specificity of TS
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto S Tagliafico, MD principal investigator
UNIGE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D mammography (Tomosynthesis) and Ultrasound in people with Breast Cancer, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Sensitivity of TS (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.