Clinical trial NCT01885143: A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
Official title: A Case Collection Study for Digital Breast Tomosynthesis (DBT) Using the Senographe Essential
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Image Correction
Keywords: Mammography
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the site's population of women recalled for further workup due to abnormalities found on screening Full-field digital Mammography exam.

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.


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

Primary outcomes:
measure: DBT in Senographe Essential is of acceptable quality according to FDA criteria
timeFrame: Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospitals
state: Michigan
Study officials:
affiliation: Beaumont Hospital System
name: Murray Rebner, MD
role: PRINCIPAL_INVESTIGATOR
References: