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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07168 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-008575 | Other Identifier | Mayo Clinic in Rochester |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (QTI) | Experimental | Patients undergo QTI ultrasound imaging on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QT Ultrasound Breast Scanner | Device | Undergo Quantitative Transmission Imaging (QTI) using the QT Ultrasound Breast Scanner |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Breasts that will fit in the quantitate transmission (QT) Ultrasound Breast Scanner (e.g. bra cup size less than DDD)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2024 | May 22, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2025 | May 22, 2026 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Questionnaire Administration | Other | Ancillary studies |
|
| D017437 |
| Skin and Connective Tissue Diseases |