Breast CarcinomaNCT07216274
Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer
A study testing QT Ultrasound Breast Scanner and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- QT Ultrasound Breast Scanner and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Quantitative Transmission Imaging Evaluation (QTIE Study) Compared With MRI as Supplemental Screening in Patients With 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.
Read the detailed description
In this prospective feasibility study, 25-30 women over the age of 18 years of age with a high lifetime risk of breast cancer >20% (as calculated by a risk assessment model such as Tyrer-Cuzick) and scheduled for a clinically ordered contrast-enhanced breast MRI were included. Exclusion criteria included pregnant or lactating patients, patients with open breast wounds or nipple discharge, patients heavier than 350 pounds, patients unable to lie prone for more than 15 minutes, and patients with a bra size larger than DDD. Enrolled patients were scheduled for a QT examination within 30 days of their clinical MRI. No additional follow-up appointments were required after the QTI exam.
Images from both imaging modalities were reviewed in consensus by four breast radiologists with 2-24 years of experience. Each interpretation was read without the benefit of prior history. The radiologists knew only that the breast MRI was a clinically indicated high-risk screening breast MRI. Since it was possible that one of the radiologists may have interpreted a breast MRI in the study, recall bias was mitigated by waiting about two months before interpreting the cases. The QTI scans were read in a randomized order. Later that same day, the MRI scans were read in randomized order. Up to three findings per breast could be reported for each imaging modality. 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.
Weighted Cohen's kappa evaluated agreement between MRI and QTI BI-RADS scores. Unweighted Cohen's kappa used after dichotomizing scores into negative (BI-RADS 1-2) vs positive (BI-RADS 3-5) categories.
- Conditions
- Breast Carcinoma
- Being tested
- QT Ultrasound Breast Scanner, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QT Ultrasound Breast ScannerDevice
Also called 3D ultrasound, QTI, QT Ultrasound, Quantitative Transmission Ultrasound (QTUS)
Undergo Quantitative Transmission Imaging (QTI) using the QT Ultrasound Breast Scanner
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (QTI) | Experimental | Patients undergo QTI ultrasound imaging on study. Receives: Device: QT Ultrasound Breast Scanner; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start31 Jul 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine U. Lee, MD, PhD, Principal investigator, Mayo Clinic in RochesterChidi T. Nwachukwu, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216274
- Sponsor's protocol ID
- 24-008575
- Other IDs
- NCI-2025-07168, 24-008575
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2025
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Transmission Imaging Evaluation (QTIE Study) Compared With MRI as Supplemental Screening in Patients With High Lifetime Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT07216274
- Acronym / sponsor ID
- 24-008575
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 14 Oct 2025 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this prospective feasibility study, 25-30 women over the age of 18 years of age with a high lifetime risk of breast cancer >20% (as calculated by a risk assessment model such as Tyrer-Cuzick) and scheduled for a clinically ordered contrast-enhanced breast MRI were included. Exclusion criteria included pregnant or lactating patients, patients with open breast wounds or nipple discharge, patients heavier than 350 pounds, patients unable to lie prone for more than 15 minutes, and patients with a bra size larger than DDD. Enrolled patients were scheduled for a QT examination within 30 days of their clinical MRI. No additional follow-up appointments were required after the QTI exam.
Images from both imaging modalities were reviewed in consensus by four breast radiologists with 2-24 years of experience. Each interpretation was read without the benefit of prior history. The radiologists knew only that the breast MRI was a clinically indicated high-risk screening breast MRI. Since it was possible that one of the radiologists may have interpreted a breast MRI in the study, recall bias was mitigated by waiting about two months before interpreting the cases. The QTI scans were read in a randomized order. Later that same day, the MRI scans were read in randomized order. Up to three findings per breast could be reported for each imaging modality. 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.
Weighted Cohen's kappa evaluated agreement between MRI and QTI BI-RADS scores. Unweighted Cohen's kappa used after dichotomizing scores into negative (BI-RADS 1-2) vs positive (BI-RADS 3-5) categories.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (QTI) | Experimental | Device: QT Ultrasound Breast Scanner, Other: Questionnaire AdministrationPatients undergo QTI ultrasound imaging on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Breasts that will fit in the quantitate transmission (QT) Ultrasound Breast Scanner (e.g. bra cup size less than DDD)
Key exclusion criteria (6 listed)
- Pregnant patients
- Lactating patients
- Patients with open wounds or discharge
- Patients < 18 years of age
- Patients who are > 350 lbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QT Ultrasound Breast ScannerAlso: 3D ultrasound, QTI, QT Ultrasound, Quantitative Transmission Ultrasound (QTUS)Undergo Quantitative Transmission Imaging (QTI) using the QT Ultrasound Breast Scanner | Device | Screening (QTI) |
| Questionnaire AdministrationAncillary studies | Other | Screening (QTI) |
Primary outcome
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed
Time frame: Baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine U. Lee, MD, PhD principal investigator
Mayo Clinic in Rochester
Chidi T. Nwachukwu, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QT Ultrasound Breast Scanner and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.