A Pilot Study - Comparison of Two Hologic 3D Mammography Systems

NCT ID: NCT00759447

Last Updated: 2019-02-22

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

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-09-30

Brief Summary

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Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

Detailed Description

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A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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3D investigational imaging

Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition

Investigational 3D Mammography system

Intervention Type DEVICE

3 dimensional breast mammography system

3D Imaging with commercial Mammography Device

Genesis and Gemini

Intervention Type DEVICE

3 dimensional breast mammography system

Interventions

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Genesis and Gemini

3 dimensional breast mammography system

Intervention Type DEVICE

Investigational 3D Mammography system

3 dimensional breast mammography system

Intervention Type DEVICE

Other Intervention Names

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Selenia Dimensions

Eligibility Criteria

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Inclusion Criteria

* Female, any ethnic origin
* No contraindication for diagnostic mammography

Exclusion Criteria

* Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
* Under 30 years of age at the time of consent
* Unable to understand and execute written informed consent
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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06-01

Identifier Type: -

Identifier Source: org_study_id

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