Image Quality Assessment for Screening and Diagnostic Mammography

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-05-31

Brief Summary

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This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

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Detailed Description

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Conditions

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Breast Health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Full Field Digital Mammography

2-dimensional breast imaging

Group Type EXPERIMENTAL

Full Field Digital Mammography

Intervention Type DEVICE

Digital Breast Tomosynthesis

3-dimensional breast imaging

Group Type EXPERIMENTAL

Digital Breast Tomosynthesis

Intervention Type DEVICE

Interventions

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Full Field Digital Mammography

Intervention Type DEVICE

Digital Breast Tomosynthesis

Intervention Type DEVICE

Other Intervention Names

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2D Mammography DBT

Eligibility Criteria

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Inclusion Criteria

1. Are women aged 40 years or older (≥40 years old);
2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
4. Are able to walk without assistive devices;
5. Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
6. Are willing to provide written informed consent to participate.

Exclusion Criteria

1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
3. Are currently lactating;
4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
5. If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No