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.

Study Overview

• Status: Completed
• Conditions: Image Correction
• Intervention / Treatment: Radiation: Digital Breast Tomosynthesis

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Artifact Correction; A minimum of 6 subjects will be recruited for the purpose of evaluating artifact correction	Radiation: Digital Breast Tomosynthesis; Other Names: DBT
Lossy Compression; A minimum of 6 subjects will be recruited for the purpose of evaluating lossy compression	Radiation: Digital Breast Tomosynthesis; Other Names: DBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DBT in Senographe Essential is of acceptable quality according to FDA criteria	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.	Phase 1_12 clinical cases read. Maximum time frame for read to result: 2 weeks

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Murray Rebner, MD, Beaumont Hospital System

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Mammography
• Other Study ID Numbers: 101.01-2013-GES-0001