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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Cases | 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 |
| |
| Recall Cases | Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography |
| |
| Screening Cases | Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFDM Mammography | Device | Standard mammography image collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Whom Study Image Data Were Collected | 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. | 20 Months |
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Inclusion Criteria:
For Screening Subjects
For Recall Subjects
For Diagnostic Subjects
Exclusion Criteria:
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A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated
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| Name | Affiliation | Role |
|---|---|---|
| Etta D Pissano, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Medical Imaging, Ltd | Scottsdale | Arizona | 85258 | United States | ||
| University of Iowa Hospitals & Clinics |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Cases | 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 |
| FG001 | Recall 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 |
| FG002 | Screening 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Cases | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Whom Study Image Data Were Collected | 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. | 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. | Posted | Count of Participants | Participants | 20 Months |
|
20 months
Same definition applies for this study as indicated from clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic Cases | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | One subject fainted during the mammogram. The enrolling center determined that the event was not related to the study procedure and not related to the investigational device. The subject fully recovered before leaving the center. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Vader | Fujifilm Medical Systems USA, Inc. | 360-356-6821 | randy.vader@fujifilm.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| DBT Mammography | Device | Collection of breast images using DBT mammography |
|
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Elizabeth Wende Breast Care, LLC | Rochester | New York | 14620 | United States |
| University of North Carolina - at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Recall 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 |
| BG002 | Screening 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Recall 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 |
| OG002 | Screening 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 |
|
|
| 0 |
| 674 |
| 0 |
| 674 |
| 1 |
| 674 |
| EG001 | Recall 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 | 0 | 203 | 0 | 203 | 0 | 203 |
| EG002 | Screening 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 | 0 | 355 | 0 | 355 | 0 | 355 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |