Computed Tomography Laser Mammography Breast Imaging Device

NCT ID: NCT00589043

Last Updated: 2015-08-25

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

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.

Detailed Description

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Conditions

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Breast Cancer

Eligibility Criteria

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Inclusion Criteria

* Female
* 21 and over
* Heterogeneously or extremely dense breast
* Schedule for biopsy
* Gave informed consent

Exclusion Criteria

* Mammogram not performed within the last 60 days
* Open lesions on the breast
* Previous breast biopsy within 60 days of the CTLM scan
* Surgical deformity of breasts
* Commercial Tattoos
* Protoporphyria
* Lactating
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Imaging Diagnostic Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Jin, MD

Role: STUDY_CHAIR

Imaging Diagnostic Systems

Central Contacts

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Debra Wood

Role: CONTACT

954-581-9800

Other Identifiers

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NA at present

Identifier Type: -

Identifier Source: org_study_id

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