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

N/AUnknownNCT02209129

Universitaire Ziekenhuizen KU Leuven1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women * more than 17% risk for breast cancer (IBIS calculation) * \> 40y old Exclusion Criteria: * \< 40y old

Locations (1)

UZLeuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Falls negative, Falls positive results, accuracy

Time frame: 4 years

Central Contacts

Chantal Van Ongeval, MD, Phd

CONTACT

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

Hilde Vandenhoutte

CONTACT

hilde.vandenhoutte@uzleuven.be

Data from ClinicalTrials.gov

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