Status:
UNKNOWN
Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
Lead Sponsor:
Prof. Paolo Bruzzi
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-59 years
Phase:
NA
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 cance...
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 mammograph...
Eligibility Criteria
Inclusion
- Women aged 40-59 years with
- cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). The lifetime cumulative risk of breast cancer will be computed using the IBIS Breast Cancer Risk Evaluation Tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. The evaluation of the composition of the mammary gland will be performed using the BI-RADS classification. Women with mammography in class 4 (i.e., \>75% of glandular component) will be eligible for randomization.
- Written Informed consent
Exclusion
- Signs or symptoms of breast cancer at enrolment;
- Previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
- BRCA or p53 mutation carrier status;
- General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
- Contraindications to any intravenous administration of contrast agent;
- Ongoing or planned pregnancy (for the duration of the study);
- Hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
- Presence of breast implants;
- Previous diagnosis of cancer at any site;
- Life-threatening diseases;
- Mental disability precluding informed consent to participate
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT02210546
Start Date
May 1 2013
End Date
September 1 2016
Last Update
August 6 2014
Active Locations (1)
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1
IRCCS Azienda Ospedaliera Universitaria S.Martino IST
Genova, Italy, 16132