Breast CancerDBTNCT01373671
Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging
A study testing SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM in people with Breast Cancer, run by Siemens Medical Solutions USA - CSG at 1 site in United States.
Trial summary
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens… Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects enrolled into the collection study must:
- Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study
- be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:
- o Normal cases at screening (BI-RADS® 1, 2 and 3):
- have a screening mammogram that includes the four standard screening views (RCC, RMLO, LCC and LMLO), as well as have both MLO and CC DBT scans of each breast,
- o Actionable cases at screening (BI-RADS® 0, 4 or 5) with final BI-RADS® 1, 2, 3, 4 or 5:
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- have a screening mammogram with four SSVs and any clinically necessary diagnostic mammographic views, such as straight lateral projections, rolled, magnification view and spot compression views, and, both MLO and CC DBT scans of each breast plus 4 SSVs repeated at the diagnostic or biopsy visit if the screening images are unavailable or were acquired more than 45 days prior to DBT acquisition,
- have supporting ground-truth documentation for the final BI-RADS® assessment as follows:
- A one (1) year FFDM follow up without evidence of cancer for normal cases not undergoing biopsy
- A six (6) or twelve (12) month FFDM follow up confirming benign status for biopsy proven benign cases
- Pathology report for either benign or malignant biopsy finding
Who cannot join
- Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:
- Pregnant women or women who believe they may be pregnant or are trying to become pregnant.
- Mastectomy patients
- Subjects who have had lumpectomy ≤ 5 years prior to the study entry
- Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals
- BI-RADS® Category 6 (e.g., for which the mammogram was performed for the purpose of planning cancer therapy)
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- BI-RADS® Category 4 or 5 without confirming pathology reports will be considered incomplete
- Subjects with mammograms that lack the required views or with views judged to be technically inadequate will be considered incomplete and the cases will not be considered for the MRMC reader studies
- Subjects being accrued from the screening population who know that they will not be in the United States or available for follow up mammograms in one year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Siemens Medical Solutions
Malvern, Pennsylvania, 19355
About this study
Official title: Multi-center Case Collection Study to Create a Library of Images From Various Approved FFDM Systems and 3D Images From Siemens Inspiration Digital Breast Tomosynthesis (DBT) System for Studies in Support of the Inspiration DBT Approval
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.
Read the detailed description
The image collection includes FFDM images and both raw and presentation data from the DBT system. The FFDM mammograms are performed using standard care screening or diagnostic mammography from various commercially available FFDM systems. All DBT images are acquired on the Inspiration DBT system specifically for the study, in addition to the clinically indicated screening mammograms. DBT images are read at the clinical sites and any DBT findings were investigated according to standard care.
- Conditions
- Breast Cancer
- Being tested
- SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM
- Keywords
- Mammography, Screening, Diagnostic
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEMDevice
DBT scan
| Study group | Role | What they receive |
|---|---|---|
| Mammography exam | Other | Siemens DBT scan Receives: Device: SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone
The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.
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 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Medical Solutions USA - CSG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnes Lazar, Siemens Medical Solutions USA, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373671
- Sponsor's protocol ID
- SMS-SP09-01
- Acronym
- DBT
- Status last verified
- Sep 2019
- First submitted
- 13 Jun 2011
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Case Collection Study to Create a Library of Images From Various Approved FFDM Systems and 3D Images From Siemens Inspiration Digital Breast Tomosynthesis (DBT) System for Studies in Support of the Inspiration DBT Approval
- ClinicalTrials.gov ID
- NCT01373671
- Acronym / sponsor ID
- DBT / SMS-SP09-01
- Conditions
- Breast Cancer
- Keywords
- Mammography, Screening, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Siemens Medical Solutions USA - CSGIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Posted 13 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.
Detailed description
The image collection includes FFDM images and both raw and presentation data from the DBT system. The FFDM mammograms are performed using standard care screening or diagnostic mammography from various commercially available FFDM systems. All DBT images are acquired on the Inspiration DBT system specifically for the study, in addition to the clinically indicated screening mammograms. DBT images are read at the clinical sites and any DBT findings were investigated according to standard care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mammography exam | Other | Device: SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEMSiemens DBT scan |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study
- be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:
- have supporting ground-truth documentation for the final BI-RADS® assessment as follows:
Key exclusion criteria (9 listed)
- Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:
- Pregnant women or women who believe they may be pregnant or are trying to become pregnant.
- Mastectomy patients
- Subjects who have had lumpectomy ≤ 5 years prior to the study entry
- Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals
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 |
|---|---|---|
| SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEMDBT scan | Device | Mammography exam |
Primary outcome
Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone
Time frame: 1 year
The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Agnes Lazar
Siemens Medical Solutions USA, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM in people with Breast Cancer, run by Siemens Medical Solutions USA - CSG at 1 site in United States.
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 11 inclusion and 9 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 7 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone (time frame: 1 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 7 Aug 2020.