Breast CancerNCT00756834
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
An observational study of Breast Cancer, run by Siemens Medical Solutions at 1 site in United States.
Trial summary
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Screening
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women 40 and older
Who may be able to join
- Mammograms obtained from women 40 years of age and over;
- Mammograms obtained from women only;
- There are at least four standard views (right cranio-caudal [RCC], right medio-lateral oblique [RMLO], left cranio-caudal [LCC], left medio-lateral oblique [LMLO]) of the breast;
- Informed consent is obtained.
- Mammograms of biopsy-proven cancer cases will be considered eligible for inclusion in the study if they meet the following criteria:
- Biopsy-proven malignant case that was assigned a BI-RADS category 4 or 5 with a suspicious lesion and the corresponding pathology report for the suspicious lesion is available.
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- Cases which have one or more lesion.
- Routine screening "Normal" cases will be considered eligible for inclusion in the study if they meet the following criteria:
- The case is a routine screening mammogram assigned a BI-RADS category 1 or 2 by a certified radiologist
Who cannot join
- Cases are excluded from the study if they have any of the following conditions:
- Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).
- The mammograms include artifacts created by breast implant.
- The mammograms are of poor quality (e.g., the digital image has very poor contrast);
- Mammograms of biopsy-proven cancer cases will be excluded from the study if they have any of the following conditions:
- Cases in which the lesion is only palpable or visible by another modality (e.g., Ultrasound, MRI).
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- The pathology is not related to a specific region. That is, there is more than one biopsy region and the pathology reports cannot be related to the appropriate mammographic lesion. For example, a mammogram with multiple lesions and multiple related pathology reports on the same date and it is not clear which pathology report belongs to each lesion.
- The pathology report is more than three months after the FFDM or FSM mammogram.
- The mammogram was performed for the purpose of planning cancer therapy (e.g., radiation) (BIRADS 6).
- Cases in which the lesion is characterized as an architectural distortion. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Siemens Medical Solutions
Malvern, Pennsylvania, 19355
About this study
Official title: A Multi-center, Controlled, Consecutive Collection of Screening or Diagnostic Full Field Digital Mammography Images Acquired on the Mammomat Novation DR System for Development and Validation of Computer Aided Detection (CAD) Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
Read the detailed description
The study design is a controlled study. The study is designed to demonstrate that the performance of the MammoDetector™ Pro on biopsy-proven malignant cases obtained with the Siemens Mammomat NovationDR FFDM system is not inferior to its performance on biopsy-proven malignant cases obtained with conventional film-screen mammography (FSM). The overall sensitivity of the MammoDetector™ Pro with both imaging modalities will be compared. Furthermore, the study is designed to demonstrate that the false marks noted by the MammoDetector™ Pro on routine screening "Normal" cases obtained with the FFDM system is not inferior those marked by the software on routine screening "Normal" cases obtained with conventional film-screen mammography (FSM).
- Conditions
- Breast Cancer
- Being tested
- Screening
- Keywords
- Breast Cancer, Computer Aided 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.
ScreeningDevice
The MammoDetector™ Pro is a computer-aided software intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the device assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review
| Study group | Role | What they receive |
|---|---|---|
| Mammography Image Collection | Acquired images Receives: Device: Screening | |
| CAD Radiologist Reader | Retrospective reader study Receives: Device: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will assess the performance of the MammoDetector™ Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat NovationDR FFDM system compared to conventional film-screen mammography (FSM).
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionAug 2020
- Study completionAug 2020
Why it stopped: No longer pursuing FDA submission/approval.
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
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Medical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louise Ebbert, Study director, Siemens Medical Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756834
- Sponsor's protocol ID
- SMS-SP04-04
- Status last verified
- Aug 2020
- First submitted
- 18 Sep 2008
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Controlled, Consecutive Collection of Screening or Diagnostic Full Field Digital Mammography Images Acquired on the Mammomat Novation DR System for Development and Validation of Computer Aided Detection (CAD) Software
- ClinicalTrials.gov ID
- NCT00756834
- Acronym / sponsor ID
- SMS-SP04-04
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Computer Aided Detection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No longer pursuing FDA submission/approval.
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Siemens Medical SolutionsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 22 Sep 2008 (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 study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
Detailed description
The study design is a controlled study. The study is designed to demonstrate that the performance of the MammoDetector™ Pro on biopsy-proven malignant cases obtained with the Siemens Mammomat NovationDR FFDM system is not inferior to its performance on biopsy-proven malignant cases obtained with conventional film-screen mammography (FSM). The overall sensitivity of the MammoDetector™ Pro with both imaging modalities will be compared. Furthermore, the study is designed to demonstrate that the false marks noted by the MammoDetector™ Pro on routine screening "Normal" cases obtained with the FFDM system is not inferior those marked by the software on routine screening "Normal" cases obtained with conventional film-screen mammography (FSM).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammography Image Collection | – | Device: ScreeningAcquired images |
| CAD Radiologist Reader | – | Device: ScreeningRetrospective reader study |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women 40 and older
Key inclusion criteria (9 listed)
- Mammograms obtained from women 40 years of age and over;
- Mammograms obtained from women only;
- There are at least four standard views (right cranio-caudal [RCC], right medio-lateral oblique [RMLO], left cranio-caudal [LCC], left medio-lateral oblique [LMLO]) of the breast;
- Informed consent is obtained.
- Mammograms of biopsy-proven cancer cases will be considered eligible for inclusion in the study if they meet the following criteria:
Key exclusion criteria (10 listed)
- Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).
- The mammograms include artifacts created by breast implant.
- The mammograms are of poor quality (e.g., the digital image has very poor contrast);
- Mammograms of biopsy-proven cancer cases will be excluded from the study if they have any of the following conditions:
- Cases in which the lesion is only palpable or visible by another modality (e.g., Ultrasound, MRI).
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 |
|---|---|---|
| ScreeningThe MammoDetector™ Pro is a computer-aided software intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the device assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review | Device | CAD Radiologist Reader, Mammography Image Collection |
Primary outcome
The study will assess the performance of the MammoDetector™ Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat NovationDR FFDM system compared to conventional film-screen mammography (FSM).
Time frame: 1 yr
Results and safety
The study was stopped early (reason given: No longer pursuing FDA submission/approval.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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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.
Louise Ebbert study director
Siemens Medical Solutions
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 Siemens Medical Solutions 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 9 inclusion and 10 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 21 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?
The study was stopped early (reason given: No longer pursuing FDA submission/approval.). 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?
The study will assess the performance of the MammoDetector™ Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat NovationDR FFDM system compared to conventional film-screen mammography (FSM). (time frame: 1 yr). 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 21 Aug 2020.