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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

Breast Cancer

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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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