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

NCT ID: NCT01885143

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Image Correction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Artifact Correction

A minimum of 6 subjects will be recruited for the purpose of evaluating artifact correction

Digital Breast Tomosynthesis

Intervention Type RADIATION

Lossy Compression

A minimum of 6 subjects will be recruited for the purpose of evaluating lossy compression

Digital Breast Tomosynthesis

Intervention Type RADIATION

Interventions

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Digital Breast Tomosynthesis

Intervention Type RADIATION

Other Intervention Names

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DBT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Murray Rebner, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital System

Locations

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Beaumont Hospitals

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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101.01-2013-GES-0001

Identifier Type: -

Identifier Source: org_study_id