Digital 3D Breast Tomosynthesis Versus 2D in Clinical Eva... | NCT02209129

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

NCT02209129

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Aug 5, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Aug 2016Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Aug 4, 2014

First Submission Date that Met QC Criteria

Aug 4, 2014

First Posted Date

Aug 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2014

Last Update Posted Date

Aug 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chantal Van Ongeval, MD, Phd, Prof. dr. Van Ongeval Chantal, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
women at high risk for breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Falls negative, Falls positive results, accuracy		4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

< 40y old

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chantal Van Ongeval, MD, Phd	Contact	+32 16 34 37 80		chantal.vanongeval@uzleuven.be
Hilde Vandenhoutte	Contact			hilde.vandenhoutte@uzleuven.be

Overall Officials

Name	Affiliation	Role
Chantal Van Ongeval, MD,Phd	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZLeuven	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided