Status:
COMPLETED
A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
Lead Sponsor:
GE Healthcare
Conditions:
Image Correction
Eligibility:
FEMALE
40+ years
Brief Summary
Collect clinical images requested by FDA with GE Breast Tomosynthesis to show they are of acceptable quality as defined in the relevant FDA guidance document before and after artifact correction and i...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Female subjects who are 40 years of age or older
- Subject has no history of symptoms and/or physical signs of breast cancer on the side of the targeted breast
- Subject underwent routine Full-Field Digital Mammography (FFDM) which showed one or more abnormalities, including calcifications, and was referred for diagnostic work-up within 4 weeks
- Subject is surgically sterile (must have documentation of bilateral oophorectomy and/or documented hysterectomy), post-menopausal (must have documentation of cessation of menses for greater than one year) or, if of childbearing potential, a documented negative urine pregnancy test within 4 weeks is required.
- Subject breast size is compatible with the dimensions of 24x31 cm of the image detector
- Subject must be in sufficient good health to be able to undergo an examination on mammography equipment as determined by the Investigator
Exclusion
- Subject or a legally authorized representative is unable to provide written informed consent
- Clinical assessment and DBT cannot be performed within 4 weeks of screening FFDM examination
- Subject is breast-feeding
- Subject has breast implants or reconstructed breasts
- Subject is undergoing radiotherapy or chemotherapy
- Subject has a history of prior radiotherapy treatment on the side of the targeted breast
- Subject has been previously enrolled in this study
- Subject is participating or has participated in another trial of an investigational product
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01885143
Start Date
August 1 2013
End Date
June 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Beaumont Hospitals
Royal Oak, Michigan, United States, 48073