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

August 19, 2020 updated by: Siemens Medical Solutions

A Multi-center, Controlled, Consecutive Collection of Screening or Diagnostic Full Field Digital Mammography Images Acquired on the Mammomat Novation DR System for Development and Validation of Computer Aided Detection (CAD) Software

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Siemens Medical Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women 40 and older

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mammography Image Collection
Acquired images
Device: 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
CAD Radiologist Reader
Retrospective reader study
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siemens Medical Solutions

Investigators

  • Study Director: Louise Ebbert, Siemens Medical Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS-SP04-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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