30 Participants Needed

Quantitative Transmission Imaging for Breast Cancer

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mayo Clinic
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 a new 3D ultrasound method called Quantitative Transmission Imaging (QTI) to evaluate its effectiveness as an additional screening tool for women at high risk of breast cancer. It compares QTI, which uses the QT Ultrasound Breast Scanner, with standard MRI scans for breast cancer screening. Women with a high lifetime risk of breast cancer who already have an MRI ordered by their doctor may be suitable candidates, particularly if their bra cup size is less than DDD. As an unphased trial, this study allows participants to contribute to innovative research that could improve breast cancer screening options.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging tests, so it's unlikely that your medications will be affected, but you should check with the trial coordinators to be sure.

What prior data suggests that the QT Ultrasound Breast Scanner is safe for breast cancer screening?

Research has shown that the QT Ultrasound Breast Scanner is a safe option for breast imaging. This scanner employs Quantitative Transmission Imaging (QTI) technology. The FDA has approved this technology, confirming it meets safety standards for medical devices.

Studies indicate that this imaging method avoids X-rays, making it safer than some other scans. It functions like a regular ultrasound, which is low-risk and easy to tolerate. QTI is considered very low-risk for both the patient and the operator.

Overall, the QT Ultrasound system is designed for safety and comfort. It does not expose users to radiation, a significant advantage for those concerned about safety in medical imaging.12345

Why are researchers excited about this trial?

The QT Ultrasound Breast Scanner is unique because it uses quantitative transmission imaging (QTI) to create detailed images of breast tissue without radiation. This method stands out from traditional mammograms and ultrasound because it promises safer, non-invasive imaging without exposure to ionizing radiation. Researchers are excited about this technology because it could provide clearer, more accurate images, potentially leading to earlier and more reliable breast cancer detection.

What evidence suggests that the QT Ultrasound Breast Scanner is effective for breast cancer screening?

Research has shown that the QT Ultrasound Breast Scanner, which participants in this trial will undergo, could be a valuable tool for women at high risk of breast cancer. Studies have found that QT imaging is as effective as mammograms, which are commonly used today, in detecting breast cancer. One study found that QT imaging was better at identifying breast lumps than traditional mammograms. This suggests it might help doctors find cancers that other methods could miss. Additionally, QT imaging is safe and painless, making it a suitable option for regular check-ups. Overall, the scanner appears promising for early detection of breast cancer.35678

Who Is on the Research Team?

CU

Christine U. Lee, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

TM

Tiffany M. Sae-Kho, MD

Principal Investigator

Mayo Clinic in Rochester

CT

Chidi T. Nwachukwu, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for asymptomatic women with a high lifetime risk of developing breast cancer. It's designed to compare the effectiveness of a new type of ultrasound called QTI against the standard MRI screening.

Inclusion Criteria

Clinical ordered screening MRI
MRI and QTI performed within 30 days of each other
I am a woman aged 18 or older.
See 2 more

Exclusion Criteria

Pregnant patients
Lactating patients
I weigh over 350 lbs.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening (QTI)

Patients undergo QTI ultrasound imaging on study

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after screening

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • QT Ultrasound Breast Scanner
Trial Overview The study is testing whether quantitative transmission imaging (QTI), which is a 3D ultrasound, can be as effective as MRI in supplemental breast cancer screening for those at high risk.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Screening (QTI)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Ultra-Low Frequency Transmitted Ultrasound Breast ...These results confirm that the QT Breast Scan is non-inferior to mammography and these data will inform decisions about whether this newer, ...
Quantitative Transmission Imaging Compared With MRI as ...Using QTI may be an effective supplemental screening tool, compared to MRI for patients with a high lifetime risk of breast cancer. Official ...
Breast ImagingQT Imaging's goal is to provide highly accurate, 100% safe and painless breast imaging that can be used to:
An Exploratory Multi-reader, Multi-case Study Comparing ...In summary, this preliminary study showed that QT imaging demonstrates improved accuracy of recalls and lesion detection as compared to FFDM. These results show ...
Quantitative Transmission ImagingMammography is ineffective in screening dense breasts. Ultrasound techniques performed after MRI did not detect additional cancer(1) in dense ...
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 ...
Safety & ComfortQTI's Breast Acoustic CT™ scanner is the only truly safe tomographic modality for breast imaging. ... And while handheld ultrasound is safe, it isn't ...
8.qtimaging.comqtimaging.com/
QT ImagingKey Clinical Highlights · Safe Breast Imaging Without X-Ray Exposure · Screening in Low Resource or Mobile Settings · Elimination of Operator Dependency · Safe ...
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