Completed

NCT Number: NCT01885143

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Image Correction

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Breast Tomosynthesis

Radiation

Other names: DBT

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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2014
First posted: Jun 24, 2013
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.