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

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ClinicalTrials.gov Identifier: NCT00756834
Recruitment Status : Terminated (No longer pursuing FDA submission/approval.)
First Posted : September 22, 2008
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Siemens Medical Solutions

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.

Condition or disease Intervention/treatment
Breast Cancer Device: Screening

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).

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : November 2006
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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). [ Time Frame: 1 yr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women 40 and older
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756834


Locations
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United States, Pennsylvania
Siemens Medical Solutions
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Siemens Medical Solutions
Investigators
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Study Director: Louise Ebbert Siemens Medical Solutions
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Responsible Party: Siemens Medical Solutions
ClinicalTrials.gov Identifier: NCT00756834    
Other Study ID Numbers: SMS-SP04-04
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Siemens Medical Solutions:
Breast Cancer
Computer Aided Detection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases