Trial Outcomes & Findings for Acquisition of Breast Mammography Images (NCT NCT02156258)

NCT ID: NCT02156258

Last Updated: 2020-05-20

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1232 participants
• Primary outcome timeframe: 20 Months
• Results posted on: 2020-05-20

Participant Flow

Participant milestones

Measure	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	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	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
Overall Study STARTED	674	203	355
Overall Study COMPLETED	642	124	244
Overall Study NOT COMPLETED	32	79	111

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acquisition of Breast Mammography Images

Baseline characteristics by cohort

Measure	Diagnostic Cases n=674 Participants 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	Recall Cases n=203 Participants 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	Screening Cases n=355 Participants 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	Total n=1232 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	518 Participants n=5 Participants	164 Participants n=7 Participants	274 Participants n=5 Participants	956 Participants n=4 Participants
Age, Categorical >=65 years	156 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants	276 Participants n=4 Participants
Sex: Female, Male Female	674 Participants n=5 Participants	203 Participants n=7 Participants	355 Participants n=5 Participants	1232 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	100 Participants n=5 Participants	32 Participants n=7 Participants	26 Participants n=5 Participants	158 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	564 Participants n=5 Participants	161 Participants n=7 Participants	316 Participants n=5 Participants	1041 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	33 Participants n=4 Participants
Region of Enrollment United States	674 participants n=5 Participants	203 participants n=7 Participants	355 participants n=5 Participants	1232 participants n=4 Participants

PRIMARY outcome

Timeframe: 20 Months

Population: 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.

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.

Outcome measures

Measure	Diagnostic Cases n=674 Participants 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	Recall Cases n=203 Participants 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	Screening Cases n=355 Participants 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
Number of Participants for Whom Study Image Data Were Collected	642 Participants	124 Participants	244 Participants

Adverse Events

Diagnostic Cases

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Recall Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Screening Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diagnostic Cases n=674 participants at risk 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	Recall Cases n=203 participants at risk 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	Screening Cases n=355 participants at risk 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
Nervous system disorders Syncope	0.15% 1/674 • Number of events 1 • 20 months Same definition applies for this study as indicated from clinicaltrials.gov.	0.00% 0/203 • 20 months Same definition applies for this study as indicated from clinicaltrials.gov.	0.00% 0/355 • 20 months Same definition applies for this study as indicated from clinicaltrials.gov.

Additional Information

Randy Vader

Fujifilm Medical Systems USA, Inc.

Phone: 360-356-6821

Email: randy.vader@fujifilm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place