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

Mayo Clinic

Status: Completed

Conditions: Breast Carcinoma

Treatments: Other: Questionnaire Administration; Device: QT Ultrasound Breast Scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT07216274

NCI-2025-07168 (Registry Identifier)

24-008575 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Screening (QTI)

Experimental group

Description:

Patients undergo QTI ultrasound imaging on study.

Treatment:

Device: QT Ultrasound Breast Scanner

Other: Questionnaire Administration