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

• Conditions: Breast Cancer

• Registration Number: NCT02209129
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study Start: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05
• Primary Completion: 2016-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• < 40y old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor dectection rate	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

Name	Time	Method
Falls negative, Falls positive results, accuracy	4 years

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium