Breast Lesion Analysis for Tomosynthesis Mammography

NCT ID: NCT00723541

Last Updated: 2020-01-21

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

Clinical Phase

NA

Total Enrollment

872 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-07-12

Brief Summary

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The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

Detailed Description

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The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (DTM).

Conditions

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Breast Cancer Abnormal Findings on Radiological Examination of Breast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Develop a computer-aided diagnostic system that will aid in the screening and detection of breast abnormalities/cancer

Group Type EXPERIMENTAL

Computer aided analysis of breast lesions

Intervention Type PROCEDURE

Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.

Interventions

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Computer aided analysis of breast lesions

Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria

* Pregnant females
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Heang-Ping Chan Ph.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heang-Ping Chan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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5R01CA151443-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM 00003483

Identifier Type: -

Identifier Source: org_study_id

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