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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02209129
• Other study ID #: B322201421047
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: August 4, 2014
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Chantal Van Ongeval, MD, Phd
• Phone: +32 16 34 37 80
• Email: chantal.vanongeval[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• women

• more than 17% risk for breast cancer (IBIS calculation)

• > 40y old

Exclusion Criteria:

• < 40y old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Falls negative, Falls positive results, accuracy		4 years	No