Ignite Creation Date:
2024-05-05 @ 11:00 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01236781
Status:
UNKNOWN
Last Update Posted:
2012-03-14
First Post:
2010-11-05
Brief Title:
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography FFDM versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening Specificity in this study will be measured by the participant call-back rate by each modality Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated Both prospective and retrospective imaging data will be assessed
Hypothesis Digital breast tomography DBT will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence
Hypothesis Digital breast tomography DBT will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence
Detailed Description:
Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography Group A A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases Group B Pregnant women women unable to tolerate compression of the breast associated with mammography women with implants and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation
A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial Group A 50 additional participants recalled for diagnostic assessment after positive screening findings will be recruited for DBT imaging data collection and retrospective image analysis Group B Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units
A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial Group A 50 additional participants recalled for diagnostic assessment after positive screening findings will be recruited for DBT imaging data collection and retrospective image analysis Group B Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None