Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography

Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography

Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography

FFDM Mammography

Collection of breast images using DBT mammography

DBT Mammography

Etta D Pissano, MD

This is a case collection study of breast images using standard and new mammography technology.

This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.

Acquisition of Breast Mammography Images

Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.

Fujifilm Medical Systems USA, Inc.

Same definition applies for this study as indicated from clinicaltrials.gov.

Collection of diagnostic cases (scheduled for biopsy due to BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography

FFDM Mammography: Standard mammography image collection

DBT Mammography: Collection of breast images using DBT mammography

Diagnostic Cases

Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography

FFDM Mammography: Standard mammography image collection

DBT Mammography: Collection of breast images using DBT mammography

Recall Cases

Collection of Screening Cases (underwent routine screening mammography) using FFDM Mammography and DBT Mammography

FFDM Mammography: Standard mammography image collection

DBT Mammography: Collection of breast images using DBT mammography

Screening Cases

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Randy Vader

Difference between enrolled and analyzed are those that were discontinued due to not returning for 1 year follow-up, etc. All cases were reviewed to ensure complete images and data, that was the extent of the analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acquisition of Breast Mammography Images	NCT02156258	Breast Cancer	FFDM Mammograph... DBT Mammography	18 Years -	Fujifilm Medical Systems USA, Inc.
Acquisition of Breast Mammography Images	NCT02156258	Breast Cancer	FFDM Mammograph... DBT Mammography	18 Years -	Fujifilm Medical Systems USA, Inc.

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