Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Cancer Risk · Breast Cancer Risk
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 40 años - 89 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- Aceptados
- Participantes
- 400 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Supplemental MRI
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.
Procedure: Magnetic resonance imaging (MRI) · Device: Artificial Intelligence (AI)
Magnetic resonance imaging (MRI) PROCEDURE
Undergo Magnetic resonance (MR) imaging
Artificial Intelligence (AI) DEVICE
AI applied to MRI images
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Cancer detection rate (CDR)
Plazo: 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.
Medidas secundarias
CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria
Plazo: 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.
Comparison of CDR in low and high TC risk groups
Plazo: 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)
Plazo: 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)
Plazo: 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)
Plazo: 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)
Plazo: 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
Plazo: 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
Plazo: Up to 1 year
The frequency of tumor stage diagnosed using the supplemental screening MRI in Mirai high risk participants will be reported.
Proportion of participants with Ki-67 expressed biomarker
Plazo: 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.
Proportion of participants with lymph node involvement detected in supplemental imaging
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (4)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
4 centros
University of California, San DiegoSan Diego, California, United StatesAún no recluta
University of California, San FranciscoSan Francisco, California, United StatesReclutando
University of Chicago Comprehensive Cancer CenterChicago, Illinois, United StatesAún no recluta
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- University of California, San Francisco
- Inicio del estudio
- 3 nov 2025 Real
- Finalización primaria
- 31 ene 2027 Estimado
- Finalización del estudio
- 31 ene 2027 Estimado
- Primera publicación
- 14 ago 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026