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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-06040 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.
PRIMARY OBJECTIVE:
I. To estimate the cancer detection rate (CDR) of supplemental screening breast MRI in participants who are high-risk by the Mirai model
SECONDARY OBJECTIVES:
I. To estimate the CDR of supplemental screening breast MRI in participants with high Mirai risk and low (<20%) lifetime Tyrer-Cuzick (TC) risk.
II. To compare the CDR of supplemental screening breast MRI in participants with high Mirai risk and high (≥ 20%) lifetime TC risk versus CDR in participants with high Mirai risk and low (<20%) lifetime TC risk.
III. To estimate the positive predictive value (PPV)1, PPV2, and PPV3 of supplemental MRI screening in participants with high Mirai risk.
IV. To estimate the false positive rate (1 - specificity) of supplemental screening MRI in participants with high Mirai risk.
V. To evaluate the tumor size, stage, grade, histological and molecular subtypes, Ki-67 percentage, and lymph node involvement of cancers detected on supplemental screening MRI in Mirai high risk participants.
VI. To evaluate the association between race/ethnicity, menopausal status, hormonal status, breast density, family history of cancer, and CDR in Mirai high-risk participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental MRI | Experimental | Participants identified as Mirai high-risk on a negative/benign screening mammogram will receive a supplemental MRI within 12 months of receiving a screening mammogram. Breast cancer risk following the Tyrer-Cuzick risk model will be assessed for comparison. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging (MRI) | Procedure | Undergo Magnetic resonance (MR) imaging |
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| Measure | Description | Time Frame |
|---|---|---|
| Cancer detection rate (CDR) | The CDR is defined as the number of breast cancers identified per 1,000 magnetic resonance imaging (MRI) screening examinations performed 1 year following supplemental screening MRI. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria | Cancer detection rate is defined as the number of breast cancers identified per 1,000 MRI screening examinations performed of supplemental screening breast MRI in participants with high Mirai risk and low (<20%) lifetime TC risk. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Screening mammogram that is assessed as BI-RADS 0 for technical recall.
Contraindications for MRI:
If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR < 30 mL/min) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Tran | Contact | 877-827-3222 | tiffany.tran3@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maggie Chung, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Not yet recruiting | San Diego | California | 92093 | United States | |
De-identified data may be shared with research collaborators during the course of the study.
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Artificial Intelligence (AI) | Device | AI applied to MRI images |
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| Comparison of CDR in low and high TC risk groups |
The CDR of supplemental screening breast MRI in participants with high Mirai risk and high (≥ 20%) lifetime TC risk versus CDR in participants with high Mirai risk and low (<20%) lifetime TC risk will be compared using a two-proportion exact test. |
| Up to 1 year |
| Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1) | PPV1 is the percentage of all positive supplemental MRI screening in participants with high Mirai risk (Breast Imaging Reporting and Data System (BI-RADS) 3, 4, or 5) for which the participant was found to be positive for cancer within 1 year from the time of MRI. | Up to 1 year |
| Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2) | PPV2 is the percentage of all supplemental MRI screenings in participants with high Mirai risk recommended for tissue diagnosis or surgical consultation (BI-RADS 4 and 5) that resulted in a histological diagnosis of cancer within 1 year. | Up to 1 year |
| Positive predictive value of biopsies resulting in histological diagnosis (PPV3) | PPV3 is the percentage of all known biopsies performed as a result of positive supplemental MRI screening (BI-RADS 4 or 5) that resulted in a tissue diagnosis of cancer within 1 year. | Up to 1 year |
| False Positive Rate (FPR) | A false positive is defined as an imaging result that incorrectly identifies a condition as present. The FPR = (False Positives / Total Tests) × 100 (or 1 - specificity) of results on supplemental screening MRIs in participants with high Mirai risk. | Up to 1 year |
| Mean tumor size detected in supplemental imaging | Mean tumor size in millimeters (mm) with in situ and invasive components separately on supplemental screening MRI in Mirai high risk participants. | Up to 1 year |
| Frequency of tumor stage detected in supplemental imaging | The frequency of tumor stage diagnosed using the supplemental screening MRI in Mirai high risk participants will be reported. | Up to 1 year |
| Proportion of participants with Ki-67 expressed biomarker | Ki-67 is divided according to percentage levels: < 15% and > 15%. The proportion of participants with pathologically confirmed Ki-67 by percentage level will be reported. | Up to 1 year |
| Proportion of participants with lymph node involvement detected in supplemental imaging | The proportion of participants with demonstrated lymph node involvement of cancers detected on the supplemental screening MRI in Mirai high risk participants. | Up to 1 year |
| Correlation between race/ethnicity and CDR | The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between race/ethnicity and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association | Up to 1 year |
| Correlation between menopausal status and CDR | The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between menopausal status and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association | Up to 1 year |
| Correlation between hormonal status and CDR | The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between hormonal status and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | Up to 1 year |
| Correlation between breast density and CDR | The Pearson correlation coefficient (r) will be used to measure the strength and direction of association between breast density and CDR. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. | Up to 1 year |
| Correlation between family history of cancer and CDR | The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between history of cancer and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | Up to 1 year |
| University of California, San Francisco |
| Recruiting |
| San Francisco |
| California |
| 94143 |
| United States |
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| University of Chicago Comprehensive Cancer Center | Not yet recruiting | Chicago | Illinois | 60637 | United States |
| University of Massachusetts Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01655 | United States |