Breast NeoplasmsPhase 4MONETNCT00302120
The MONET - Study: MR Mammography of Nonpalpable Breast Tumors
A Phase 4 study testing Contrast-enhanced MR mammography in people with Breast Neoplasms, run by UMC Utrecht at 3 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Contrast-enhanced MR mammography
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2006to Mar 2010
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)
- referred for large core needle biopsy
- 18 to 75 years
Who cannot join
- previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography
- pregnant or lactating
- claustrophobia or adiposity ( > 130 kg)
- general contraindications for MRI
- unable to maintain prone position for one hour
- medically unstable patients
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Meander Medisch Centrum
Amersfoort, 3818 ES
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, 3300 AK
- Recruiting
Unicersity Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: MR Mammography: Randomized Controlled Trial to Study Efficiency of MR Mammography in Reducing the Number of Invasive Interventions in Nonpalpable Suspicious Breast Lesions. The MONET - Study
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.
Read the detailed description
Each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the Netherlands. In the usual care situation, these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material. In case of malignancy, these lesions are surgically removed. First, a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion. Unfortunately about 25% of women require more that one surgical procedure to remove all tumorous tissue. This is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease (multifocality, multicentricity, lymph node involvement). We hypothesize that MR mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures (primary outcome) and number of invasive biopsies (secondary outcome).
- Conditions
- Breast Neoplasms
- Being tested
- Contrast-enhanced MR mammography
- Keywords
- Magnetic Resonance Imaging, Breast Neoplasms, Diagnostic Trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced MR mammographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.
Measured: 2010
Secondary outcomes (1)
The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Willem P Mali, MD PhD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302120
- Sponsor's protocol ID
- UMC Utrecht
- Acronym
- MONET
- Status last verified
- Jun 2008
- First submitted
- 10 Mar 2006
- Last updated
- 10 Jun 2008
- Results posted
- No
Publications
Peters NH, Borel Rinkes IH, Mali WP, van den Bosch MA, Storm RK, Plaisier PW, de Boer E, van Overbeeke AJ, Peeters PH. Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome - MONET - study. Trials. 2007 Nov 28;8:40. doi: 10.1186/1745-6215-8-40.
PubMed 18045470
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Mammography: Randomized Controlled Trial to Study Efficiency of MR Mammography in Reducing the Number of Invasive Interventions in Nonpalpable Suspicious Breast Lesions. The MONET - Study
- ClinicalTrials.gov ID
- NCT00302120
- Acronym / sponsor ID
- MONET / UMC Utrecht
- Conditions
- Breast Neoplasms
- Keywords
- Magnetic Resonance Imaging, Breast Neoplasms, Diagnostic Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Mar 2006 (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.
The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.
Detailed description
Each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the Netherlands. In the usual care situation, these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material. In case of malignancy, these lesions are surgically removed. First, a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion. Unfortunately about 25% of women require more that one surgical procedure to remove all tumorous tissue. This is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease (multifocality, multicentricity, lymph node involvement). We hypothesize that MR mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures (primary outcome) and number of invasive biopsies (secondary outcome).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)
- referred for large core needle biopsy
- 18 to 75 years
Key exclusion criteria (6 listed)
- previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography
- pregnant or lactating
- claustrophobia or adiposity ( > 130 kg)
- general contraindications for MRI
- unable to maintain prone position for one hour
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 |
|---|---|---|
| Contrast-enhanced MR mammography | Procedure or surgery | – |
Primary outcome
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group.
Time frame: 2010
1 secondary outcome
The number of large core needle biopsies that can be prevented because of a definite diagnosis as provided by MRI will be calculated.
Time frame: 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
- Derived from this study: PubMed 18045470Peters NH, Borel Rinkes IH, Mali WP, van den Bosch MA, Storm RK, Plaisier PW, de Boer E, van Overbeeke AJ, Peeters PH. Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome - MONET - study. Trials. 2007 Nov 28;8:40. doi: 10.1186/1745-6215-8-40.
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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.
Willem P Mali, MD PhD study director
UMC Utrecht
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrast-enhanced MR mammography in people with Breast Neoplasms, run by UMC Utrecht at 3 sites in Netherlands.
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 6 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 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nicky HG Peters, MD (0031302503196, n.peters@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute number of surgical procedures in women with nonpalpable malignancies will be compared between MRI group and control group. (time frame: 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00302120, which also lists 1 linked publication.
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 10 Jun 2008.