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

NCT00756834 | Terminated FDA Device

• 1 other identifier: SMS-SP04-04
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Computer Aided Detection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mammography Image Collection

Acquired images

Device: Screening

CAD Radiologist Reader

Retrospective reader study

Device: Screening

Interventions

Screening 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; Mammography Image Collection

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women 40 and older

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.
• 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.
• 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. -

Sponsors & Collaborators

• Siemens Medical Solutions: lead

Study Sites (1)

Siemens Medical Solutions

Malvern, Pennsylvania, 19355, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Louise Ebbert

  Siemens Medical Solutions

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: November 1, 2006
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)