Mammographic Breast DensityNCT04127175
Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size
An observational study of Mammographic Breast Density, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. Read more about this study
- Who is it for?
- Ages 40 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammographic Breast Density
- What is being tested?
- Volpara
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to Aug 2020
- 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 40 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic women with age greater than 40 who has signed a consent form.
Who may be able to join
- Acceptance of participation through a signed consent form.
- Asymptomatic subjects
Who cannot join
- Subjects refusing to participate or sign the consent form.
- Subjects with prior history of breast surgery or biopsy with markers.
- Subjects with breast prostheses.
- Subjects with biopsy marker clips
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Radiology Breast Unit, Hospital Parc Taulí
Sabadell, Barcelona, 08208
Javier del Riego, MD, +34 93 717 11 54 ext. 26 001, jdelriego@tauli.cat
Oliver Diaz, PhD
About this study
Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um).
This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.
Read the detailed description
Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed.
Inclusion criteria:
- Subjects over 18 years old.
- Acceptance of participation through a signed consent form.
- Asymptomatic subjects
Exclusion criteria:
- Subjects refusing to participate or sign the consent form.
- Subjects with prior history of breast surgery or biopsy with markers.
- Subjects with breast prostheses.
- Conditions
- Mammographic Breast Density
- Being tested
- Volpara
- Keywords
- Breast cancer, Breast density, Volpara, Quantra, BI-RADS, Digital Mammography, Digital Breast Tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolparaDevice
This tool represents a physics-based model which extract pixel-wise information from the FFDM or DBT images, and combine it with metadata information from the DICOM header and appropriate linear attenuation coefficients of both adipose and glandular tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode).
Measured: 1 year
Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Oct 2019
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammographic Breast DensityStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Universitat de Girona
- Responsible party
- Principal investigator, Oliver Diaz-Montesdeoca, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127175
- Sponsor's protocol ID
- 2019/629
- Status last verified
- Jul 2020
- First submitted
- 12 Oct 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size
- ClinicalTrials.gov ID
- NCT04127175
- Acronym / sponsor ID
- 2019/629
- Conditions
- Mammographic Breast Density
- Keywords
- Breast cancer, Breast density, Volpara, Quantra, BI-RADS, Digital Mammography, Digital Breast Tomosynthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- University of Barcelona, Universitat de Girona
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- 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 (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um).
This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.
Detailed description
Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed.
Inclusion criteria:
- Subjects over 18 years old.
- Acceptance of participation through a signed consent form.
- Asymptomatic subjects
Exclusion criteria:
- Subjects refusing to participate or sign the consent form.
- Subjects with prior history of breast surgery or biopsy with markers.
- Subjects with breast prostheses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic women with age greater than 40 who has signed a consent form.
Key inclusion criteria (2 listed)
- Acceptance of participation through a signed consent form.
- Asymptomatic subjects
Key exclusion criteria (4 listed)
- Subjects refusing to participate or sign the consent form.
- Subjects with prior history of breast surgery or biopsy with markers.
- Subjects with breast prostheses.
- Subjects with biopsy marker clips
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 |
|---|---|---|
| VolparaThis tool represents a physics-based model which extract pixel-wise information from the FFDM or DBT images, and combine it with metadata information from the DICOM header and appropriate linear attenuation coefficients of both adipose and glandular tissue. | Device | – |
Primary outcome
Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode).
Time frame: 1 year
Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Breast density software which will be evaluatedLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Mammographic Breast Density, run by Corporacion Parc Tauli at 1 site in Spain.
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 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 22 Jul 2020. 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 Spain. 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 Oliver Diaz, PhD (+34 93 402 08 55, oliver.diaz@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode). (time frame: 1 year). 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?
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 22 Jul 2020.