Breast CancerMRIBNCT02210546
Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk
A study testing Magnetic Resonance Imaging (MRI) and Mammography (Mx) + ultrasonography (US) in people with Breast Cancer, run by Prof. Paolo Bruzzi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Mammography (Mx) + ultrasonography (US)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliera Universitaria S.Martino IST
Genova, 16132
Paolo Bruzzi, MD, +390105558476, paolo.bruzzi@hsanmartino.it
Paolo Bruzzi, MD
About this study
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.
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:
- Yearly two-view mammography (Mx) and breast ultrasonography (US) or
- Yearly MRI.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Magnetic Resonance Imaging (MRI), Mammography (Mx) + ultrasonography (US)
- Keywords
- breast cancer, intermediate risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
Mammography (Mx) + ultrasonography (US)Other
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Experimental | Patients will undergo MRI yearly Receives: Other: Magnetic Resonance Imaging (MRI) |
| Mammography (Mx) + ultrasonography (US) | Other | Patients will undergo yearly two-view (Mx) and breast US Receives: Other: Mammography (Mx) + ultrasonography (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 years
Proportion of the different histological characteristics of cancers detected in the two arms
Measured: 3 years
Number of invasive diagnostic procedures in the two study arms.
Measured: 3 years
Number of interval cancers in the two study arms.
Measured: 3 years
Rate of eligible women who accept to enter the study.
Measured: 3 years
Compliance to the intervention in the two study arms.
Measured: 3 years
Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms
Measured: 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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Paolo Bruzzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Paolo Bruzzi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Antonella Petrillo, MD, Principal investigator, Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)Paolo Belli, MD, Principal investigator, Policlinico Gemelli (Rome)Alessandro Del Maschio, MD, Principal investigator, Ospedale san Raffaele (Milan)Laura Martincich, MD, Principal investigator, IRCCS Candiolo (Turin)Massimo Bazzocchi, MD, Principal investigator, AOU S.Maria della Misericordia (Udine)Piero Panizza, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)Stefania Montemezzi, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaFederica Pediconi, MD, Principal investigator, Azienda Policlinico Umberto I (Rome)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210546
- Sponsor's protocol ID
- RF-2009-1539582
- Acronym
- MRIB
- Status last verified
- Aug 2014
- First submitted
- 27 May 2013
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02210546
- Acronym / sponsor ID
- MRIB / RF-2009-1539582
- Conditions
- Breast Cancer
- Keywords
- breast cancer, intermediate risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Prof. Paolo BruzziUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Yearly two-view mammography (Mx) and breast ultrasonography (US) or
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Experimental | Other: Magnetic Resonance Imaging (MRI)Patients will undergo MRI yearly |
| Mammography (Mx) + ultrasonography (US) | Other | Other: Mammography (Mx) + ultrasonography (US)Patients will undergo yearly two-view (Mx) and breast US |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | Magnetic Resonance Imaging (MRI) |
| Mammography (Mx) + ultrasonography (US) | Other | Mammography (Mx) + ultrasonography (US) |
Primary outcome
Rate of in situ and invasive breast cancers detected in the two arms of the study
Time frame: 36 months
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
8 secondary outcomes
Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study
Time frame: 3 years
Proportion of the different histological characteristics of cancers detected in the two arms
Time frame: 3 years
Number of invasive diagnostic procedures in the two study arms.
Time frame: 3 years
Number of interval cancers in the two study arms.
Time frame: 3 years
Rate of eligible women who accept to enter the study.
Time frame: 3 years
Compliance to the intervention in the two study arms.
Time frame: 3 years
Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms
Time frame: 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
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Petrillo, MD principal investigator
Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)
Paolo Belli, MD principal investigator
Policlinico Gemelli (Rome)
Alessandro Del Maschio, MD principal investigator
Ospedale san Raffaele (Milan)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Mammography (Mx) + ultrasonography (US) in people with Breast Cancer, run by Prof. Paolo Bruzzi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Bruzzi, MD (+390105558476, paolo.bruzzi@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of in situ and invasive breast cancers detected in the two arms of the study (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.