Breast CancerTOMUSNCT03033030
Tomosynthesis (TS) or Ultrasound (US) in Mammography-negative Dense Breasts (TOMUS). National Multicenter Trial
An observational study of Breast Cancer, run by University of Genova at 1 site in Italy.
Trial summary
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Sep 2021
- Phase
- Observational
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who undergo breast TS and Mammography
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 BI- RADS D1-2.
- Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BI-RADS 3-4.
- 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
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate [7,8,9]. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy [10].
Read the detailed description
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy.
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
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 we aim to:
- Assess if TS may detect additional cancers in dense breasts that approximate US detection capability but with less false positive findings than US.
- If TS detects new cancers in dense breasts similarly to US (approximate rate or marginally lower rate), evaluate the true positive/false positive ratio.
- Cost-analysis. In case of less false positives detected by TS, the TP/ FP trade-off might be strongly in favour of TS with a great potential of costs reduction.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound
- Keywords
- Ultrasound, Digital Breast Tomosynthesis, Cancer Detection rate, Sensitivity, Specificity, Breast density
- Medical subject headings
- Breast Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis | Patients undergoing Digital Breast Tomosynthesis Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cancer Detection Rate or Area Under the Curve
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
Measured: 2 years
Secondary outcomes (1)
TP/FP rate
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 we aim to:
- Assess if TS may detect additional cancers in dense breasts that approximate US detection capability but with less false positive findings than US.
- If TS detects new cancers in dense breasts similarly to US (approximate rate or marginally lower rate), evaluate the true positive/false positive ratio.
- Cost-analysis. In case of less false positives detected by TS, the TP/ FP trade-off might be strongly in favour of TS with a great potential of costs reduction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startFeb 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Tagliafico, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033030
- Sponsor's protocol ID
- 102REG2016
- Acronym
- TOMUS
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomosynthesis (TS) or Ultrasound (US) in Mammography-negative Dense Breasts (TOMUS). National Multicenter Trial
- ClinicalTrials.gov ID
- NCT03033030
- Acronym / sponsor ID
- TOMUS / 102REG2016
- Conditions
- Breast Cancer
- Keywords
- Ultrasound, Digital Breast Tomosynthesis, Cancer Detection rate, Sensitivity, Specificity, Breast density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 Jan 2017 (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.
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate [7,8,9]. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy [10].
Detailed description
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy.
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
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 we aim to:
- Assess if TS may detect additional cancers in dense breasts that approximate US detection capability but with less false positive findings than US.
- If TS detects new cancers in dense breasts similarly to US (approximate rate or marginally lower rate), evaluate the true positive/false positive ratio.
- Cost-analysis. In case of less false positives detected by TS, the TP/ FP trade-off might be strongly in favour of TS with a great potential of costs reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis | – | Diagnostic Test: UltrasoundPatients undergoing Digital Breast Tomosynthesis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who undergo breast TS and Mammography
Key inclusion criteria (3 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 BI- RADS D1-2.
- Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BI-RADS 3-4.
- 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 |
|---|---|---|
| UltrasoundUltrasound examination | Diagnostic test | Tomosynthesis |
Primary outcome
Incremental Cancer Detection Rate or Area Under the Curve
Time frame: 2 years
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
1 secondary outcome
TP/FP rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 26 Jan 2017. 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?
Incremental Cancer Detection Rate or Area Under the Curve (time frame: 2 years). 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 26 Jan 2017.