Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer

This clinical trial compares the use of quantitative transmission imaging (QTI) to standard of care MRI as a supplemental screening tool for patients with a high lifetime risk of breast cancer. QTI is a single 3D ultrasound test intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer. Using QTI may be an effective supplemental screening tool, compared to MRI for patients with a high lifetime risk of breast cancer.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women 18+ years of age
High lifetime risk of breast cancer as determined by a risk assessment tool such a Tyrer-Cuzick model
Clinical ordered screening MRI.

MRI and QTI performed within 30 days of each other
Breasts that will fit in the quantitate transmission (QT) Ultrasound Breast Scanner (e.g. bra cup size less than DDD)

Exclusion criteria

Pregnant patients
Lactating patients
Patients with open wounds or discharge
Patients < 18 years of age
Patients who are > 350 lbs
Patients who are unable to lay prone for >15 minutes

Treatment and study plan

QT Ultrasound Breast Scanner

Device

Undergo Quantitative Transmission Imaging (QTI) using the QT Ultrasound Breast Scanner

Other names: 3D ultrasound, QTI, QT Ultrasound, Quantitative Transmission Ultrasound (QTUS), Quantitative Transmission Imaging

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

Detectability of positive exam findings (feasibility)

Time frame: Baseline

Assessed by description of the number of positive findings. Breast Imaging Reporting and Data System (BIRADS) classification of the screening exam and potential diagnostic work up may allow for calculation of positive predictive value (PPV)1 and PPV3. If biopsies are obtained, then findings will be compared to histopathologic diagnosis.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Quantitative Transmission Imaging Evaluation (QTIE Study) Compared With MRI as Supplemental Screening in Patients With High Lifetime Risk of Breast Cancer

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 14, 2025
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed