NCT02209129

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

August 4, 2014

Last Update Submit

August 4, 2014

Conditions

Breast Cancer

Keywords

digital breast tomosynthesis

Outcome Measures

Primary Outcomes (1)

  • Tumor dectection rate

    The addititional value of 3D tomosythesis to 2D digital mammography will be evaluated by the cancer detection rate, falls negative and falls positive results.

    2 years

Secondary Outcomes (1)

  • Falls negative, Falls positive results, accuracy

    4 years

Study Arms (1)

women at high risk for breast cancer

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \< 40y old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chantal Van Ongeval, MD,Phd

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Van Ongeval, MD, Phd

CONTACT

+32 16 34 37 80chantal.vanongeval@uzleuven.be

Hilde Vandenhoutte

CONTACT

hilde.vandenhoutte@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Van Ongeval Chantal

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

BE(1)