NCT02948361

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2016Dec 2026

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

10.3 years

First QC Date

September 1, 2016

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Marin Breast Health Trial Center

Novato, California, 94949, United States

Location

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 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)