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

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ClinicalTrials.gov Identifier: NCT02209129
Recruitment Status : Unknown
Verified August 2014 by Chantal Van Ongeval, MD, Phd, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3D Digital Breast Tumorsynthesis Versus 2D Digital Mammography in the Clinical Evaluation of Women at High Risk for Breast Cancer
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

women at high risk for breast cancer

Outcome Measures

Primary Outcome Measures :
  1. Tumor dectection rate [ Time Frame: 2 years ]
    The addititional value of 3D tomosythesis to 2D digital mammography will be evaluated by the cancer detection rate, falls negative and falls positive results.

Secondary Outcome Measures :
  1. Falls negative, Falls positive results, accuracy [ Time Frame: 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with an increased risk for breast cancer > 17% according to the IBIS calculation, and also defined by the Multidisciplinary Breast centre UZ Leuven, Belgium

Inclusion Criteria:

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

Exclusion Criteria:

  • < 40y old
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209129

Contact: Chantal Van Ongeval, MD, Phd +32 16 34 37 80 chantal.vanongeval@uzleuven.be
Contact: Hilde Vandenhoutte hilde.vandenhoutte@uzleuven.be

UZLeuven Recruiting
Leuven, Belgium, 3000
Contact: Chantal Van Ongeval    +3216343780    chantal.vanongeval@uzleuven.be   
Principal Investigator: Chantal Van Ongeval, MD,Phd         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Chantal Van Ongeval, MD,Phd Universitaire Ziekenhuizen Leuven
More Information

Responsible Party: Chantal Van Ongeval, MD, Phd, Prof. dr. Van Ongeval Chantal, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02209129     History of Changes
Other Study ID Numbers: B322201421047
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Chantal Van Ongeval, MD, Phd, Universitaire Ziekenhuizen Leuven:
digital breast tomosynthesis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases