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

(PROGRESS Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: QT Ultrasound LLC

Disqualifiers: Infection, Allergies, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1500 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the QT Ultrasound Breast Scan treatment?

Research shows that QT Ultrasound is promising for breast imaging, offering high resolution and contrast, which helps in detecting and diagnosing breast cancer effectively. It has been compared favorably to traditional mammography in terms of recall and detection rates, especially in women with dense breast tissue. ^{1 2 3 4 5}

Is the QT Ultrasound Breast Scan safe for humans?

The QT Ultrasound Breast Scan, used as an adjunct to mammography, is considered safe and can improve cancer detection, especially in women with dense breasts. However, it may increase the rate of false-positive results, which can lead to unnecessary anxiety and procedures. ^{4 5 6 7 8}

How does the QT Ultrasound Breast Scan treatment differ from other breast cancer detection methods?

The QT Ultrasound Breast Scan is unique because it uses Quantitative Transmission (QT) ultrasound technology, which provides high-resolution, three-dimensional images with a high contrast to noise ratio, allowing for better evaluation of breast tissue compared to traditional mammography. It can distinguish different types of breast tissue with high accuracy by measuring the speed of sound through the tissue, offering a non-invasive and radiation-free alternative for breast cancer detection. ^{1 2 9 10 11}

What is the purpose of this trial?

This trial uses the QT Ultrasound Breast Scanner to check for abnormalities in women's breast tissue. If any unusual findings are detected, additional imaging tests like mammograms or hand-held ultrasounds will be performed. The scanner works by using sound waves to create detailed images of the breast. QT Ultrasound is an emerging imaging method known for its high resolution and ability to clearly show breast tissue.

Eligibility Criteria

Inclusion Criteria

Willing and able to provide written, signed informed consent

Willing and able to comply with all study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

QT Ultrasound Scanning

Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects with findings, standard imaging modalities will be performed per ACR recommendations.

2 to 3 hours per session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the scanning session

2-4 weeks

Treatment Details

Interventions

• QT Ultrasound Breast Scan

Participant Groups

Group I: QT Ultrasound breast scan Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

QT Ultrasound LLC

Lead Sponsor

Trials

5

Recruited

2,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative transmission ultrasound tomography: Imaging and performance characteristics. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

An Exploratory Multi-reader, Multi-case Study Comparing Transmission Ultrasound to Mammography on Recall Rates and Detection Rates for Breast Cancer Lesions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Connecticut Experiment; The Third Installment: 4 Years of Screening Women with Dense Breasts with Bilateral Ultrasound. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Effect of Targeted Ultrasound as Primary Imaging Modality on Quality of Life in Women with Focal Breast Complaints: A Comparative Cohort Study. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Advantages and limitations of breast ultrasound]. [2017]

6. Canada pubmed.ncbi.nlm.nih.gov

Women's Experiences of Inaccurate Breast Cancer Screening Results: A Systematic Review and Qualitative Meta-synthesis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Breast density measurements using ultrasound tomography for patients undergoing tamoxifen treatment. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Reducing Unnecessary Biopsies Using Digital Breast Tomosynthesis and Ultrasound in Dense and Nondense Breasts. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Anatomy-Correlated Breast Imaging and Visual Grading Analysis Using Quantitative Transmission Ultrasound™. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

[New aspects in ultrasound mammography (author's transl)]. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Breast Ultrasound: Indications and Findings. [2017]