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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Chantal Van Ongeval, MD, Phd, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT02209129
First received: August 4, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Tumor dectection rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Falls negative, Falls positive results, accuracy [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
women at high risk for breast cancer

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 40y old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02209129

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

Locations
Belgium
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
Investigators
Principal Investigator: Chantal Van Ongeval, MD,Phd Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

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
Study First Received: August 4, 2014
Last Updated: August 4, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
digital breast tomosynthesis

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

ClinicalTrials.gov processed this record on October 19, 2014