Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk

NCT02210546 | Unknown

• 1 other identifier: RF-2009-1539582
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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. 1.Yearly two-view mammography (Mx) and breast ultrasonography (US) or
2. 2.Yearly MRI.

Conditions

Breast Cancer

Keywords

breast cancer; intermediate risk

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

Magnetic Resonance Imaging (MRI)

EXPERIMENTAL

Patients will undergo MRI yearly

Other: Magnetic Resonance Imaging (MRI)

Mammography (Mx) + ultrasonography (US)

OTHER

Patients will undergo yearly two-view (Mx) and breast US

Other: Mammography (Mx) + ultrasonography (US)

Interventions

Magnetic Resonance Imaging (MRI) OTHER

Magnetic Resonance Imaging (MRI)

Mammography (Mx) + ultrasonography (US) OTHER

Mammography (Mx) + ultrasonography (US)

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Paolo Bruzzi: lead

Study Sites (1)

IRCCS Azienda Ospedaliera Universitaria S.Martino IST

Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Antonella Petrillo, MD

  Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)

  PRINCIPAL INVESTIGATOR

• Paolo Belli, MD

  Policlinico Gemelli (Rome)

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Paolo Bruzzi, MD

CONTACT

+390105558476; paolo.bruzzi@hsanmartino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: August 6, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

IT (1)