CClinicalTrials.gg
Enrolling by invitationNCT02948361PROGRESSUpdated Jan 7, 2026

Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS

An interventional study of QT Ultrasound Breast Scan in Volunteer Subjects, sponsored by QT Ultrasound LLC. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by QT Ultrasound LLC · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Volunteer Subjects
03

In context

Lead sponsor

QT Ultrasound LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 18 years old
  • Willing and able to provide written, signed informed consent
  • Willing and able to comply with all study procedures

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    QT Ultrasound breast scan

    Other: QT Ultrasound Breast Scan

Interventions

  • OtherQT Ultrasound Breast Scan

    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.

06

What researchers measure

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

    Time frame: Scan session is 2 to 3 hours

07

Study locations

1 site
  • Marin Breast Health Trial Center
    Novato, California 94949, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02948361
Lead sponsor
QT Ultrasound LLC
Responsible party
Sponsor
First posted
Oct 28, 2016
Start date
Aug 2016
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 7, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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