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

NCT07216274 | Completed FDA Device

• 2 other identifiers: 24-008575NCI-2025-07168
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Detectability of positive exam findings (feasibility)

  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.

  Baseline

Study Arms (1)

Screening (QTI)

EXPERIMENTAL

Patients undergo QTI ultrasound imaging on study.

Device: QT Ultrasound Breast Scanner; Other: Questionnaire Administration

Interventions

QT Ultrasound Breast Scanner DEVICE

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

Also known as: 3D ultrasound, QTI, QT Ultrasound, Quantitative Transmission Ultrasound (QTUS), Quantitative Transmission Imaging

Screening (QTI)

Questionnaire Administration OTHER

Ancillary studies

Screening (QTI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Tiffany M. Sae-Kho, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Christine U. Lee, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Chidi T. Nwachukwu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: July 31, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)