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

Completed

Conditions studied: Image Correction

In brief

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.

Key facts

Study ID

NCT01885143

Run by

GE Healthcare

People needed

80

Starts

2013-08-01

Expected to finish

2014-06-01

Last updated by the study team

2014-12-02

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beaumont Hospitals — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.