Clinical trial · Interventional
Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer
Quantitative Transmission Imaging Evaluation (QTIE Study) Compared With MRI as Supplemental Screening in Patients With High Lifetime Risk of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QT Ultrasound Breast Scanner | Device | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (QTI)
- description
- Patients undergo QTI ultrasound imaging on study.
- interventionNames
- Device: QT Ultrasound Breast Scanner
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Number of Findings for the Total MRI Interpretations and Total QTI Interpretations Performed
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available