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

NCT ID: NCT00756834

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2020-08-31

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).

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Mammography Image Collection

Acquired images

Screening

Intervention Type: DEVICE

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

CAD Radiologist Reader

Retrospective reader study

Screening

Intervention Type: DEVICE

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

Interventions

Screening

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Mammograms obtained from women 40 years of age and over;

2. Mammograms obtained from women only;

3. 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;

4. 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:

5. 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.

6. 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:

7. The case is a routine screening mammogram assigned a BI-RADS category 1 or 2 by a certified radiologist

Exclusion Criteria

Cases are excluded from the study if they have any of the following conditions:

1. Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).

2. The mammograms include artifacts created by breast implant.

3. 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:

4. Cases in which the lesion is only palpable or visible by another modality (e.g., Ultrasound, MRI).

5. 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.

6. The pathology report is more than three months after the FFDM or FSM mammogram.

7. The mammogram was performed for the purpose of planning cancer therapy (e.g., radiation) (BIRADS 6).

8. Cases in which the lesion is characterized as an architectural distortion. -

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Siemens Medical Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Ebbert

Role: STUDY_DIRECTOR

Siemens Medical Solutions

Locations

Siemens Medical Solutions

Malvern, Pennsylvania, United States

Countries

United States

Other Identifiers

SMS-SP04-04

Identifier Type: -

Identifier Source: org_study_id