Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software

Stopped early

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00756834

Run by

Siemens Medical Solutions

People needed

135

Starts

2006-11-01

Expected to finish

2020-08-01

Last updated by the study team

2020-08-21

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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. -

Where it is running

• Siemens Medical Solutions — Malvern, Pennsylvania, United States

Full record on ClinicalTrials.gov

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