NCT02948361

Enrolling By Invitation

Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BRe...

QT Ultrasound LLC Source

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Other study identifiers

Sponsor study identifier

BR004

Study Type

interventional

Estimated enrollment

1,500

Locations

1 country

Sites

1

Timeline

Study Start

August 2016

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations. If available, subjects may provide copies of their breast imaging exams and related reports. Demographics and medical history will be collected.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: enrolling by invitation
Estimated enrollment: 1,500 participants
Study completion date: December 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2016
Actual (reported)
First Submitted
September 1, 2016
Actual (reported)
First Posted
October 28, 2016
Actual (reported)
Primary Completion
December 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: January 7, 2026
Status Verified: January 2026
Last Update Submitted: January 5, 2026

Conditions

Volunteer Subjects

Outcome Measures

Primary Outcomes (1)

QT Ultrasound scans
The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session
Scan session is 2 to 3 hours

Study Arms (1)

QT Ultrasound breast scan

EXPERIMENTAL

Other: QT Ultrasound Breast Scan

Interventions

QT Ultrasound Breast ScanOther

Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per American College of Radiology (ACR) recommendations.

QT Ultrasound breast scan

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

At least 18 years old
Willing and able to provide written, signed informed consent

Sponsors & Collaborators

QT Ultrasound LLC
Industrylead

Study Sites (1)

Marin Breast Health Trial Center

Novato, California, 94949, United States

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

October 28, 2016

Study Start

August 2016

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Willing and able to comply with all study procedures

You may not qualify if:

Inability to tolerate the scan
Present infection risk
Allergies to device materials
Inability to successfully "fit" breast into the investigational device
Currently pregnant as reported by the subject
Body weight greater than 400 lbs. (180 kg)
Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results

Contact the study team to confirm eligibility.

Study Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02948361
Data provider: ClinicalTrials.gov
Source updated: 2026-01-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:08 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

QT Ultrasound breast scan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations