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Case Collection Study to Support Digital Mammography Image Software Change

NCT ID: NCT00756496

Last Updated: 2020-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-01-31

Brief Summary

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The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Mammography screening and diagnosis

Intervention Type DEVICE

Mammography screening and diagnosis

Interventions

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Mammography screening and diagnosis

Mammography screening and diagnosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female
* \> 40 years

Exclusion Criteria

* Pregnant women, or women who may become pregnant
* Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
* Palpable lesion or one that is visible by another modality
* Inmates
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Siemens Medical Solutions USA - CSG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond C Duhamel, Ph.D.

Role: STUDY_DIRECTOR

Siemens Medical Solutions USA, Inc

Other Identifiers

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SMS-SP04-06

Identifier Type: -

Identifier Source: org_study_id