Spots Global Cancer Trial Database for Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
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Trial Identification
Brief Title: Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
Official Title: A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.
Study ID: NCT02210546
Conditions
Study Description
Brief Summary: 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: 1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or 2. Yearly MRI.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
IRCCS Azienda Ospedaliera Universitaria S.Martino IST, Genova, , Italy
Contact Details
Name: Antonella Petrillo, MD
Affiliation: Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Belli, MD
Affiliation: Policlinico Gemelli (Rome)
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandro Del Maschio, MD
Affiliation: Ospedale san Raffaele (Milan)
Role: PRINCIPAL_INVESTIGATOR
Name: Laura Martincich, MD
Affiliation: IRCCS Candiolo (Turin)
Role: PRINCIPAL_INVESTIGATOR
Name: Massimo Bazzocchi, MD
Affiliation: AOU S.Maria della Misericordia (Udine)
Role: PRINCIPAL_INVESTIGATOR
Name: Piero Panizza, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)
Role: PRINCIPAL_INVESTIGATOR
Name: Stefania Montemezzi, MD
Affiliation: Azienda Ospedaliera Universitaria Integrata Verona
Role: PRINCIPAL_INVESTIGATOR
Name: Federica Pediconi, MD
Affiliation: Azienda Policlinico Umberto I (Rome)
Role: PRINCIPAL_INVESTIGATOR
Name: Stefano Corcione, MD
Affiliation: Azienda Ospedaliero Universitaria (Ferrara)
Role: PRINCIPAL_INVESTIGATOR
Name: Massimo Calabrese, MD
Affiliation: IRCCS AOU S. Martino-IST (Genoa)
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Sardanelli, MD
Affiliation: IRCCS San Donato (Milan)
Role: PRINCIPAL_INVESTIGATOR
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