Breast NeoplasmsNCT01524029
Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
An observational study of Breast Neoplasms, run by Medical University of Vienna at 5 sites in Austria.
Trial summary
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- How many people
- 600 participants
- Where
- 5 sitesAustria
- Study dates
- Jan 2012to Dec 2012
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of two groups: One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination. The second group consists of women aged 25+ referred for further examination of a breast lesion.
Who may be able to join
- Age > 25 years (40 years or older for Screening Cohort)
- No history of breast cancer
- Written informed consent
- Asymptomatic women in follow up for early detection of breast cancer or
- Patients with a recent positive mammography (BI-RADS 3-5)
Who cannot join
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites, 5 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, A-8036
Sabine Oswald, MD, +43 316385 ext. 13850, sabine.oswald@klinikum-graz.at
- Recruiting
Medical University of Vienna
Vienna, A-1090
Thomas Moritz, MD, +43140400 ext. 4818, thomas.moritz@meduniwien.ac.at
- Recruiting
Kaiser Franz Josef Spital
Vienna, A-1100
Gabrielle Kienzer, MD, +43160191 ext. 3608, Gabrielle.kienzer@wienkav.at
- Recruiting
Hanusch Krankenhaus
Vienna, A-1140
Reinhard Bernt, MD, +43191021 ext. 86630, reinhard.bernt@wgkk.at
- Recruiting
Klinikum Wels-Grieskirchen
Wels, Upper Austria, A-4600
Stefan Meindl, MD, +437242415 ext. 2413, stefan.meindl@klinikum-wegr.at
About this study
Official title: Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.
DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.
This is a study conducted in several Austrian Breast Imaging Centers.
Read the detailed description
This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.
DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.
Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.
Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
- Conditions
- Breast Neoplasms
- Keywords
- Digital Breast Tomosynthesis, Digital Mammography, Breast cancer detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Screening Patients | Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site | |
| Diagnostic Patients | Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Measured: One year
Secondary outcomes (1)
Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Moritz, Medical University of Vienna
- Investigators
- Thomas Moritz, MD, Principal investigator, Medical University of ViennaThomas Helbich, MD Prof. MBA MSc, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524029
- Sponsor's protocol ID
- TomoTrial001
- Status last verified
- Jan 2012
- First submitted
- 29 Jan 2012
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
- ClinicalTrials.gov ID
- NCT01524029
- Acronym / sponsor ID
- TomoTrial001
- Conditions
- Breast Neoplasms
- Keywords
- Digital Breast Tomosynthesis, Digital Mammography, Breast cancer detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Feb 2012 (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.
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.
DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.
This is a study conducted in several Austrian Breast Imaging Centers.
Detailed description
This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.
DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.
Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.
Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Screening Patients | – | –Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site |
| Diagnostic Patients | – | –Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of two groups: One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination. The second group consists of women aged 25+ referred for further examination of a breast lesion.
Key inclusion criteria (5 listed)
- Age > 25 years (40 years or older for Screening Cohort)
- No history of breast cancer
- Written informed consent
- Asymptomatic women in follow up for early detection of breast cancer or
- Patients with a recent positive mammography (BI-RADS 3-5)
Key exclusion criteria (4 listed)
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written 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.
Primary outcome
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Time frame: One year
1 secondary outcome
Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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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.
Thomas Moritz, MD principal investigator
Medical University of Vienna
Thomas Helbich, MD Prof. MBA MSc study director
Medical University of Vienna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Medical University of Vienna at 5 sites in Austria.
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 5 inclusion and 4 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. 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?
Contact Thomas Moritz, MD (+43140400 ext. 4818, thomas.moritz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions (time frame: One year). 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 1 Feb 2012.