QT Ultrasound for Breast Imaging

(PROGRESS Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: QT Ultrasound LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the QT Ultrasound Breast Scanner, a new imaging device for examining the breast. The goal is to determine how well this scanner identifies breast calcifications, masses, or other unusual findings compared to standard imaging methods like mammograms. Researchers seek volunteers who can undergo the scan and provide their breast imaging history, if available. Suitable candidates for this trial are at least 18 years old and can comply with study procedures. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative breast imaging technology.

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 prior data suggests that the QT Ultrasound Breast Scanner is safe?

Research has shown that the QT Ultrasound Breast Scanner is designed to be very safe. Studies have found that it uses very low-frequency sound waves, similar to other low-risk ultrasound systems. The FDA has approved the device, confirming it meets safety standards for use.

The QT Ultrasound system creates a complete 3D image of the breast, unlike traditional handheld ultrasounds. It is both safe and painless, offering a comfortable choice for breast imaging. No major safety issues have been reported, making it a promising option for those considering participation in this clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about the QT Ultrasound Breast Scan because it offers a radiation-free alternative to traditional mammograms and breast MRIs for breast imaging. Unlike other imaging methods that use X-rays or strong magnetic fields, the QT Ultrasound uses sound waves to create detailed images of breast tissue, which could be safer and more comfortable for patients. This innovative approach might lead to earlier and more accurate detection of breast abnormalities, potentially improving outcomes and reducing the need for invasive procedures.

What evidence suggests that the QT Ultrasound Breast Scan is effective for breast imaging?

Research has shown that the QT Ultrasound Breast Scan, which participants in this trial will receive, is effective for breast imaging. Studies have demonstrated that this system performs as well as traditional mammograms in detecting breast issues. In one study, experts using QTscan images correctly identified 92% of cysts and solid lumps. Another study found that QT imaging had a slightly lower rate of recalling patients for further cancer checks compared to standard mammograms, but the difference was not significant. Overall, the QT Ultrasound Breast Scan serves as a reliable alternative for breast imaging.45678

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to provide written, signed informed consent
Willing and able to comply with all study procedures

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • QT Ultrasound Breast Scan
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: QT Ultrasound breast scanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

QT Ultrasound LLC

Lead Sponsor

Trials
5
Recruited
2,600+

Citations

Ultra-Low Frequency Transmitted Ultrasound Breast ...The Cronbach's alpha for QT scan was 0.82 [95% CI: 0.78, 0.86]. For mammogram, Cronbach's alpha was 0.87 [0.85, 0.90]. Both of these results ...
QT imaging's breast imaging system proves as effective as ...QT imaging's breast imaging system proves as effective as mammography. The QTI Breast Acoustic CT system is an imaging technique that provides ...
An Exploratory Multi-reader, Multi-case Study Comparing ...QT imaging showed a slight, but statistically nonsignificant decrease of 2% in the cancer recall rate compared to FFDM. These results suggest that QT imaging ...
Completed Clinical StudiesUsing QTscan images and the SoS, compared with mammogram images, readers were able to achieve 92% accuracy in distinguishing a cyst from solid lesion.
Quantitative transmission ultrasound tomography: Imaging ...The results show an improvement in the imaging performance of the system in comparison to earlier ultrasound tomography systems, which are applicable to ...
Safety & ComfortAnd while handheld ultrasound is safe, it isn't tomographic – only QTI delivers full-volume, 3D imaging with complete safety, making it ideal for women of all ...
K220933 Trade/Device Name: QT Scann - accessdata.fda.govThe QT Scanner 2000 Model A software also calculates the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast ...
Breast ImagingQT Imaging's goal is to provide highly accurate, 100% safe and painless breast imaging that can be used to: Identify cancer early to minimize invasiveness and ...
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