Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
- Conditions
- Breast Cancer
- Registration Number
- NCT00756834
- Lead Sponsor
- Siemens Medical Solutions
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 135
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Mammograms obtained from women 40 years of age and over;
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Mammograms obtained from women only;
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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;
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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:
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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:
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The case is a routine screening mammogram assigned a BI-RADS category 1 or 2 by a certified radiologist
Cases are excluded from the study if they have any of the following conditions:
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Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).
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The mammograms include artifacts created by breast implant.
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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:
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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.
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The pathology report is more than three months after the FFDM or FSM mammogram.
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The mammogram was performed for the purpose of planning cancer therapy (e.g., radiation) (BIRADS 6).
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Cases in which the lesion is characterized as an architectural distortion. -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). 1 yr
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Siemens Medical Solutions
🇺🇸Malvern, Pennsylvania, United States
Siemens Medical Solutions🇺🇸Malvern, Pennsylvania, United States