Breast 3DUS ABUS System Comparison | NCT06118996

Studies
Breast 3DUS ABUS System Comparison

NCT06118996

Sponsor

Western University, Canada

Status

Recruiting

Last Update Posted

Apr 13, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Breast Diseases

Interventions

3D Ultrasound Image Acquisition

Countries

Canada

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2024Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Oct 31, 2023

First Submission Date that Met QC Criteria

Oct 31, 2023

First Posted Date

Nov 7, 2023Actual

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

Apr 9, 2025

Last Update Posted Date

Apr 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients at Risk of Breast Cancer	Experimental	These patients will be imagined with an experimental device designed to acquire ultrasound in three dimensional volumes	Device: 3D Ultrasound Image Acquisition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D Ultrasound Image Acquisition	Device	A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.	Patients at Risk of Breast Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breast Images	Images of the breast anatomy will be compared to standard of care imaging.	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Patients who are scheduled for screening ABUS
Adults Patients who are scheduled for short term follow-up with ABUS.
Must be at least 18 years of age or older.
Must be proficient in English (reading/writing).

Exclusion Criteria:

Patients with breast implants.
Patients with contraindication for ABUS.
Patients who cannot tolerate ABUS.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anat Kornecki, MD	Contact	519-646-6100		Anat.Kornecki@sjhc.london.on.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital	Recruiting	London	Ontario	N6A 4V2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided