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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (QTI)

Patients undergo QTI ultrasound imaging on study.

Group Type EXPERIMENTAL

QT Ultrasound Breast Scanner

Intervention Type DEVICE

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

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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QT Ultrasound Breast Scanner

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

Intervention Type DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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3D ultrasound QTI QT Ultrasound Quantitative Transmission Ultrasound (QTUS) Quantitative Transmission Imaging

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes