Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
NCT ID: NCT02948361
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
1500 participants
INTERVENTIONAL
2016-08-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
If available, subjects may provide copies of their breast imaging exams and related reports.
Demographics and medical history will be collected.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Case Collection Study to Determine the Accuracy, Call Back and Cancer Detection Rates of QT Ultrasound in Breast Imaging
NCT03052166
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
NCT02133417
Automated Breast Ultrasound Screening
NCT02650778
Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
NCT03470051
Quantitative Subharmonic Breast Imaging
NCT01490892
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QT Ultrasound breast scan
QT 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QT 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing and able to provide written, signed informed consent
* Willing and able to comply with all study procedures
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
QT Ultrasound LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marin Breast Health Trial Center
Novato, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BR004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.