Breast Density Measurements in Digital Mammography and Br... | NCT04127175

Studies
Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size

NCT04127175

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Jul 22, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Mammographic Breast Density

Interventions

Volpara

Countries

Spain

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

Jul 2020

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

Oct 1, 2019Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Oct 12, 2019

First Submission Date that Met QC Criteria

Oct 12, 2019

First Posted Date

Oct 15, 2019Actual

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

Jul 21, 2020

Last Update Posted Date

Jul 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Diaz-Montesdeoca, Visiting researcher, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Name	Class
University of Barcelona	OTHER
Universitat de Girona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um).

This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.

Detailed Description

Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed.

Inclusion criteria:

Subjects over 18 years old.
Acceptance of participation through a signed consent form.
Asymptomatic subjects

Exclusion criteria:

Subjects refusing to participate or sign the consent form.
Subjects with prior history of breast surgery or biopsy with markers.
Subjects with breast prostheses.

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

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Volpara	Device	This tool represents a physics-based model which extract pixel-wise information from the FFDM or DBT images, and combine it with metadata information from the DICOM header and appropriate linear attenuation coefficients of both adipose and glandular tissue.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode).		1 year
Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acceptance of participation through a signed consent form.
Asymptomatic subjects

Exclusion Criteria:

Subjects refusing to participate or sign the consent form.
Subjects with prior history of breast surgery or biopsy with markers.
Subjects with breast prostheses.
Subjects with biopsy marker clips

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Asymptomatic women with age greater than 40 who has signed a consent form.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oliver Diaz, PhD	Contact	+34 93 402 08 55		oliver.diaz@ub.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiology Breast Unit, Hospital Parc Taulí	Recruiting	Sabadell	Barcelona	08208	Spain

References Module

Citations

Not provided

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