A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Image Correction
- Sponsor
- GE Healthcare
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- DBT in Senographe Essential is of acceptable quality according to FDA criteria
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 in standard screening images. Lossy compression will also be evaluated to demonstrate that images are of acceptable quality when lossy compression is enabled.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
DBT in Senographe Essential is of acceptable quality according to FDA criteria
Time Frame: Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 weeks
Collect 12 clinical DBT cases with MLO and CC views taken from the Senographe Essential to assess whether the DBT in Senographe Essential is of acceptable quality according to FDA criteria following the clinical evaluation instructions described in Section 9 of the guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System". Assessment will include review of images with and without artifact correction and with and without lossy compression and findings will be included in PMA submission.