Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women

NCT ID: NCT02209129

Last Updated: 2014-08-05

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-08-31

Brief Summary

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Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation) will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo) of both breasts in two views in order to investigate the additional value of tomosynthesis in the diagnosis of breast cancer.

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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women at high risk for breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* women
* more than 17% risk for breast cancer (IBIS calculation)
* \> 40y old

Exclusion Criteria

* \< 40y old
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Chantal Van Ongeval, MD, Phd

Prof. dr. Van Ongeval Chantal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chantal Van Ongeval, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZLeuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Chantal Van Ongeval, MD, Phd

Role: CONTACT

+32 16 34 37 80

Hilde Vandenhoutte

Role: CONTACT

Facility Contacts

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Chantal Van Ongeval

Role: primary

+3216343780

Other Identifiers

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B322201421047

Identifier Type: -

Identifier Source: org_study_id

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