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

3D Digital Breast Tumorsynthesis Versus 2D Digital Mammography in the Clinical Evaluation of Women at High Risk for Breast Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02209129

Enrollment

1000

Registered

2014-08-05

Start date

2014-08-31

Completion date

2017-08-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

digital breast tomosynthesis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* \< 40y old

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Falls negative, Falls positive results, accuracy	4 years

Countries

Belgium

Contacts

Primary ContactChantal Van Ongeval, MD, Phd

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

Backup ContactHilde Vandenhoutte

hilde.vandenhoutte@uzleuven.be

Outcome results