Breast CancerNCT02698202
Screening for Breast Cancer With Digital Breast Tomosynthesis
A study testing Digital Breast Tomosynthesis in people with Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Digital Breast Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,877 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2014to 31 Dec 2019
- 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-70 years old women invited to breast cancer screening program who accepted to participate
Who cannot join
- previous breast cancer diagnosis
- pregnancy or suspicion of pregnancy
- presence of BRCA1/2 gene mutation
- Previous Digital Breast Tomosynthesis performed
- unable to understand informed consent
- chemotherapy in progress
- presence of breast implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Read the detailed description
The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).
Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
- Conditions
- Breast Cancer
- Being tested
- Digital Breast Tomosynthesis
- Keywords
- Tomosynthesis,sensitivity,specificity,screening,mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast TomosynthesisDevice
twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Digital Breast Tomosynthesis | Experimental | to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis Receives: Device: Digital Breast Tomosynthesis |
| standard mammography | No intervention | to the control arm the usual 2D standard mammography exam will be offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of T2+ cancers after screening
Measured: 2 years
incidence of interval cancers
Measured: 2 years
Secondary outcomes (8)
Detection rate
Measured: 2 years
recall rate
Measured: baseline
Positive Predictive value
Measured: baseline
diagnostic agreement between tomosynthesis and 2d mammography
Measured: baseline
Detection rate of in situ ductal carcinoma
Measured: 2 years
biopsy rate
Measured: baseline
self-reported pain and discomfort during mammography
Measured: baseline
x-ray dose
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start10 Mar 2014
- Primary completion31 Jul 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 26,877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- Regione Emilia-Romagna
- Responsible party
- Sponsor
- Investigators
- Pierpaolo Pattacini, MD, Principal investigator, Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698202
- Sponsor's protocol ID
- ReTomo
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.
PubMed 35103537
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
- ClinicalTrials.gov ID
- NCT02698202
- Acronym / sponsor ID
- ReTomo
- Conditions
- Breast Cancer
- Keywords
- Tomosynthesis,sensitivity,specificity,screening,mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,877 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- Regione Emilia-Romagna
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Mar 2016 (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.
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Detailed description
The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).
Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Breast Tomosynthesis | Experimental | Device: Digital Breast Tomosynthesisto the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis |
| standard mammography | No intervention | –to the control arm the usual 2D standard mammography exam will be offered |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 45-70 years old women invited to breast cancer screening program who accepted to participate
Key exclusion criteria (7 listed)
- previous breast cancer diagnosis
- pregnancy or suspicion of pregnancy
- presence of BRCA1/2 gene mutation
- Previous Digital Breast Tomosynthesis performed
- unable to understand informed consent
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 |
|---|---|---|
| Digital Breast Tomosynthesistwice screening examination: standard 2D mammography + Digital Breast Tomosynthesis | Device | Digital Breast Tomosynthesis |
Primary outcome
cumulative incidence of T2+ cancers after screening
Time frame: 2 years
incidence of interval cancers
Time frame: 2 years
8 secondary outcomes
Detection rate
Time frame: 2 years
recall rate
Time frame: baseline
Positive Predictive value
Time frame: baseline
diagnostic agreement between tomosynthesis and 2d mammography
Time frame: baseline
Detection rate of in situ ductal carcinoma
Time frame: 2 years
biopsy rate
Time frame: baseline
self-reported pain and discomfort during mammography
Time frame: baseline
x-ray dose
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 35103537Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.
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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.
Pierpaolo Pattacini, MD principal investigator
Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Breast Tomosynthesis in people with Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of T2+ cancers after screening (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698202, which also lists 1 linked publication.
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 19 Dec 2025.