Breast Cancer Risk, Cancer Risk
Conditions
Keywords
Screening, BI-RADS
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMagnetic resonance imaging (MRI)
Undergo Magnetic resonance (MR) imaging
DEVICEArtificial Intelligence (AI)
AI applied to MRI images
Sponsors
Breast Cancer Research Foundation
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
1. All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2. 2. Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk). 3. Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images. 4. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Screening mammogram that is assessed as BI-RADS 0 for technical recall. 2. Contraindications for MRI: 1. Metallic foreign body in the eye. 2. MRI unsafe implants and/or medical devices. 3. Adverse reaction to a (gadolinium-based) contrast agent in the past. 4. Pregnant women. 5. Claustrophobia. 6. Exceeds site specific size and/or weight limit for MRI. 3. 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: 1. History of kidney disease as an adult, including renal tumor or transplant. 2. Diabetes treated with insulin or other prescribed medications. 3. Hypertension (high blood pressure) requiring medication. 4. Multiple myeloma. 5. Solid organ transplant. 6. History of severe hepatic disease/liver transplant/pending liver transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer detection rate (CDR) | Up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of CDR in low and high TC risk groups | Up to 1 year | 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. |
| Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1) | Up to 1 year | 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. |
| Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2) | Up to 1 year | 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. |
| Positive predictive value of biopsies resulting in histological diagnosis (PPV3) | Up to 1 year | 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. |
| False Positive Rate (FPR) | Up to 1 year | 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. |
| Mean tumor size detected in supplemental imaging | Up to 1 year | Mean tumor size in millimeters (mm) with in situ and invasive components separately on supplemental screening MRI in Mirai high risk participants. |
| Frequency of tumor stage detected in supplemental imaging | Up to 1 year | The frequency of tumor stage diagnosed using the supplemental screening MRI in Mirai high risk participants will be reported. |
| CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria | Up to 1 year | 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. |
| Proportion of participants with lymph node involvement detected in supplemental imaging | Up to 1 year | The proportion of participants with demonstrated lymph node involvement of cancers detected on the supplemental screening MRI in Mirai high risk participants. |
| Correlation between race/ethnicity and CDR | Up to 1 year | 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 |
| Correlation between menopausal status and CDR | Up to 1 year | 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 |
| Correlation between hormonal status and CDR | Up to 1 year | 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. |
| Correlation between breast density and CDR | Up to 1 year | 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. |
| Correlation between family history of cancer and CDR | Up to 1 year | 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. |
| Proportion of participants with Ki-67 expressed biomarker | Up to 1 year | 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. |
Countries
United States
Contacts
Primary ContactTiffany Tran
Outcome results
None listed