Status:
TERMINATED
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
Lead Sponsor:
Siemens Medical Solutions
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
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 fi...
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 Novation...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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).
- 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. -
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00756834
Start Date
November 1 2006
End Date
August 1 2020
Last Update
August 21 2020
Active Locations (1)
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1
Siemens Medical Solutions
Malvern, Pennsylvania, United States, 19355