Breast NeoplasmsNCT02771444
Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
A study testing Tomo Assessment in people with Breast Neoplasms, run by Philips Digital Mammography Sweden AB at 1 site in Italy.
Trial summary
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Tomo Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2016to 22 Mar 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 40 years of age
- Has a tomosynthesis examination with comparator
- Has a mammographic finding
Who cannot join
- Pregnant, breastfeeding or believes she may be pregnant
- Unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.
Read the detailed description
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.
The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.
- Conditions
- Breast Neoplasms
- Being tested
- Tomo Assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomo AssessmentDevice
Also called MicroDose Tomosynthesis
A four-view tomosynthesis examination
| Study group | Role | What they receive |
|---|---|---|
| Tomo Assessment | Experimental | Subjects will have a 4-view tomosynthesis examination with the study device. Receives: Device: Tomo Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray dose
X-ray dose will be measured per projection.
Measured: 4 months
Secondary outcomes (1)
Lesion conspicuity comparison of images from study device vs comparator
Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startDec 2016
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Why it stopped: Decision by sponsor, development stopped.
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 NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Digital Mammography Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pietro Panizza, M.D, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771444
- Sponsor's protocol ID
- DOC-EMOA-A7UDZ2
- Status last verified
- Jan 2018
- First submitted
- 10 May 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Venturini E, Losio C, Rodighiero M, Ferrarese G, Del Vecchio A, Loria A, Rehn JR, Panizza P. Low dose photon-counting digital breast tomosynthesis: comparison with a commercially available tomosynthesis unit in the detection and characterization of breast carcinomas. Radiol Med. 2026 Jan;131(1):11-20. doi: 10.1007/s11547-025-02115-7. Epub 2025 Oct 4.
PubMed 41045355
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
- ClinicalTrials.gov ID
- NCT02771444
- Acronym / sponsor ID
- DOC-EMOA-A7UDZ2
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision by sponsor, development stopped.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Philips Digital Mammography Sweden ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 13 May 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.
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.
Detailed description
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.
The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomo Assessment | Experimental | Device: Tomo AssessmentSubjects will have a 4-view tomosynthesis examination with the study device. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman over 40 years of age
- Has a tomosynthesis examination with comparator
- Has a mammographic finding
Key exclusion criteria (2 listed)
- Pregnant, breastfeeding or believes she may be pregnant
- Unable or unwilling to give 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 |
|---|---|---|
| Tomo AssessmentAlso: MicroDose TomosynthesisA four-view tomosynthesis examination | Device | Tomo Assessment |
Primary outcome
X-ray dose
Time frame: 4 months
X-ray dose will be measured per projection.
1 secondary outcome
Lesion conspicuity comparison of images from study device vs comparator
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Decision by sponsor, development stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Derived from this study: PubMed 41045355Venturini E, Losio C, Rodighiero M, Ferrarese G, Del Vecchio A, Loria A, Rehn JR, Panizza P. Low dose photon-counting digital breast tomosynthesis: comparison with a commercially available tomosynthesis unit in the detection and characterization of breast carcinomas. Radiol Med. 2026 Jan;131(1):11-20. doi: 10.1007/s11547-025-02115-7. Epub 2025 Oct 4.
- Individual participant dataSharing planned: No
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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.
Pietro Panizza, M.D principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomo Assessment in people with Breast Neoplasms, run by Philips Digital Mammography Sweden AB 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Mar 2018. 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 was stopped early (reason given: Decision by sponsor, development stopped.). Results are not available in the source record.
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?
X-ray dose (time frame: 4 months). 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 NCT02771444, 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 26 Mar 2018.