Digital Breast Tomosynthesis in Younger Symptomatic Women

NCT ID: NCT01241981

Last Updated: 2018-05-08

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

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2018-02-28

Brief Summary

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This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Digital Breast Tomosynthesis

Digital Breast Tomosynthesis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Female
* Under 60 years old
* Clinical or ultrasound suspicion of breast cancer

Exclusion Criteria

* Unable to give informed consent
* Male
* Obvious advanced breast cancer
* Obvious medical problems meaning surgery would not be an option
Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Dundee

OTHER

Sponsor Role collaborator

NHS Tayside

OTHER_GOV

Sponsor Role lead

Responsible Party

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Andy Evans

Professor of Breast Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew J Evans, FRCR

Role: PRINCIPAL_INVESTIGATOR

University of Dundee, NHS Tayside

Locations

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NHS Tayside, Ninewells Hospital & Medical School

Dundee, Tayside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2010ON15

Identifier Type: -

Identifier Source: org_study_id

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