Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS (PROGRESS)
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ClinicalTrials.gov Identifier: NCT02948361 |
Recruitment Status :
Active, not recruiting
First Posted : October 28, 2016
Last Update Posted : April 22, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Volunteer Subjects | Other: QT Ultrasound Breast Scan | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1500 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS |
Study Start Date : | August 2016 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: QT Ultrasound breast scan |
Other: 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. |
- QT Ultrasound scans [ Time Frame: Scan session is 2 to 3 hours ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948361
United States, California | |
Marin Breast Health Trial Center | |
Novato, California, United States, 94949 |
Responsible Party: | QT Ultrasound LLC |
ClinicalTrials.gov Identifier: | NCT02948361 |
Other Study ID Numbers: |
BR004 |
First Posted: | October 28, 2016 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |