Trial Outcomes & Findings for Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer (NCT NCT07216274)

Last Updated: 2026-08-20

Results Overview

Assessed by the number of positive findings. For each finding, imaging characteristics, size, and location were recorded. A Breast Imaging Reporting and Data System (BI-RADS) score was assigned for each finding. If biopsies are obtained, then findings will be compared to histopathologic diagnosis.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Baseline

Results posted on

2026-08-20

Participant Flow

Women over the age of 18 with a high lifetime risk of breast cancer (\>20% lifetime risk as based on an assessment model such as Tyrer-Cuzick). Patients that were recruited for the study already had a clinically ordered breast Magnetic Resonance Imaging (MRI) screening scheduled and after consent to study participation agreed to complete the Quantitative Transmission Imaging (QTI) within 30 days of completing clinical breast MRI screening.

Participant milestones

Participant milestones
Measure	Screening (QTI) Patients undergo QTI ultrasound imaging on study.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening (QTI) n=26 Participants Patients undergo QTI ultrasound imaging on study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: For the 26 patients, each breast was interpreted separately for each imaging modality, yielding 52 MRI interpretations and 52 QTI interpretations.

Outcome measures

Outcome measures
Measure	QTI Interpretatoins n=52 breasts Patients undergo QTI ultrasound imaging on study.	MRI Interpretations n=52 breasts Patients undergo magnetic resonance imaging (MRI) on study.
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed No findings	37 Number of findings	34 Number of findings
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed One finding	17 Number of findings	13 Number of findings
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed Two findings	2 Number of findings	1 Number of findings

Adverse Events

Screening (QTI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine U. Lee, MD, PhD

Mayo Clinic

Phone: 507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place