Volunteer SubjectsPROGRESSNCT02948361
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
A study testing QT Ultrasound Breast Scan in people with Volunteer Subjects, run by QT Ultrasound LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Volunteer Subjects
- What is being tested?
- QT Ultrasound Breast Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Willing and able to provide written, signed informed consent
- Willing and able to comply with all study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Marin Breast Health Trial Center
Novato, California, 94949
About this study
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.
- Conditions
- Volunteer Subjects
- Being tested
- QT Ultrasound Breast Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| QT Ultrasound breast scan | Experimental | Not described Receives: Other: QT Ultrasound Breast Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Scan session is 2 to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volunteer SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QT Ultrasound LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948361
- Sponsor's protocol ID
- BR004
- Acronym
- PROGRESS
- Status last verified
- Jan 2026
- First submitted
- 1 Sep 2016
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
- ClinicalTrials.gov ID
- NCT02948361
- Acronym / sponsor ID
- PROGRESS / BR004
- Conditions
- Volunteer Subjects
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- QT Ultrasound LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QT Ultrasound breast scan | Experimental | Other: QT Ultrasound Breast Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Willing and able to provide written, signed informed consent
- Willing and able to comply with all study procedures
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QT Ultrasound Breast ScanSubjects 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. | Other | QT Ultrasound breast scan |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Volunteer Subjects
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
COLLECT BLOOD/RESEARCH USE
Blood Donors, Research Subjects
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QT Ultrasound Breast Scan in people with Volunteer Subjects, run by QT Ultrasound LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT Ultrasound scans (time frame: Scan session is 2 to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.