A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential

General Electric (GE)

Status

Completed

Conditions

Image Correction

Treatments

Radiation: Digital Breast Tomosynthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT01885143

101.01-2013-GES-0001

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

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