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A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer.
Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to:
Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Experimental | Patients will undergo MRI yearly |
|
| Mammography (Mx) + ultrasonography (US) | Other | Patients will undergo yearly two-view (Mx) and breast US |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other |
| ||
| Mammography (Mx) + ultrasonography (US) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of in situ and invasive breast cancers detected in the two arms of the study | The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study | 3 years | |
| Proportion of the different histological characteristics of cancers detected in the two arms | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bruzzi, MD | Contact | +390105558476 | paolo.bruzzi@hsanmartino.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonella Petrillo, MD | Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples) | Principal Investigator |
| Paolo Belli, MD | Policlinico Gemelli (Rome) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliera Universitaria S.Martino IST | Recruiting | Genova | 16132 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D000069453 | Ultrasonic Waves |
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| Other |
|
| Number of invasive diagnostic procedures in the two study arms. | 3 years |
| Number of interval cancers in the two study arms. | 3 years |
| Rate of eligible women who accept to enter the study. | 3 years |
| Compliance to the intervention in the two study arms. | 3 years |
| Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms | 3 years |
| Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up | 10 years |
| Alessandro Del Maschio, MD |
| Ospedale san Raffaele (Milan) |
| Principal Investigator |
| Laura Martincich, MD | IRCCS Candiolo (Turin) | Principal Investigator |
| Massimo Bazzocchi, MD | AOU S.Maria della Misericordia (Udine) | Principal Investigator |
| Piero Panizza, MD | Fondazione IRCCS Istituto Nazionale dei Tumori (Milan) | Principal Investigator |
| Stefania Montemezzi, MD | Azienda Ospedaliera Universitaria Integrata Verona | Principal Investigator |
| Federica Pediconi, MD | Azienda Policlinico Umberto I (Rome) | Principal Investigator |
| Stefano Corcione, MD | Azienda Ospedaliero Universitaria (Ferrara) | Principal Investigator |
| Massimo Calabrese, MD | IRCCS AOU S. Martino-IST (Genoa) | Principal Investigator |
| Francesco Sardanelli, MD | IRCCS San Donato (Milan) | Principal Investigator |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |