Breast CancerMETAMARBONCT01291082
Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)
An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Breast Cancer
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Aug 2013
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- Patients with a proven breast cancer (by biopsy or imaging)
- Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
- Patient with an informed consent.
Who cannot join
- Patients with a single bone metastasis treated by Radiotherapy will be excluded.
- Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
- Claustrophobia
- Patient in a bad general condition.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Steven Pans, MD, 003216340505, steven.pans@uzleuven.be
Steven Pans, MD
About this study
Official title: Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.
Read the detailed description
About 50 patients with a proven breast cancer and bone metastases will be included.
First step : staging
- nuclear bone scan
- Positron Emission Tomography (PET/CT)
- MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration
Aim :
- Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
- To calculate cut-off values for DWI for bone and visceral metastases.
Second step : therapy follow-up/therapy assessment.
- Two groups of patients (oncologist takes the decision about therapy)
- Patients treated by chemotherapy
- Patients treated by hormonal therapy
- on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body MR (same protocol, no contrast) will be performed.
End-point:
Whole body MR with DWI is useful and reliable to assess the treatment response.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, metastasis, bone, diffusion MRI
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Breast cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of whole body diffusion weighted MRI in breastcancer patients
whole body MRI will be correlated to the nucleair bone scan and PET-CT
Measured: 6 months
Secondary outcomes (1)
Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013 (estimated)
- Study completionAug 2013 (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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Pans, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Steven Pans, MD, Principal investigator, UZ Leuven Dept Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291082
- Sponsor's protocol ID
- S53057
- Acronym
- METAMARBO
- Status last verified
- Jan 2013
- First submitted
- 3 Feb 2011
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)
- ClinicalTrials.gov ID
- NCT01291082
- Acronym / sponsor ID
- METAMARBO / S53057
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, metastasis, bone, diffusion MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 7 Feb 2011 (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.
Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.
Detailed description
About 50 patients with a proven breast cancer and bone metastases will be included.
First step : staging
- nuclear bone scan
- Positron Emission Tomography (PET/CT)
- MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration
Aim :
- Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
- To calculate cut-off values for DWI for bone and visceral metastases.
Second step : therapy follow-up/therapy assessment.
- Two groups of patients (oncologist takes the decision about therapy)
- Patients treated by chemotherapy
- Patients treated by hormonal therapy
- on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body MR (same protocol, no contrast) will be performed.
End-point:
Whole body MR with DWI is useful and reliable to assess the treatment response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | –Breast cancer patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (3 listed)
- Patients with a proven breast cancer (by biopsy or imaging)
- Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
- Patient with an informed consent.
Key exclusion criteria (4 listed)
- Patients with a single bone metastasis treated by Radiotherapy will be excluded.
- Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
- Claustrophobia
- Patient in a bad general condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of whole body diffusion weighted MRI in breastcancer patients
Time frame: 6 months
whole body MRI will be correlated to the nucleair bone scan and PET-CT
1 secondary outcome
Whole body MRI with diffusion weighted imaging is a reliable imaging tool for therapy assessment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Steven Pans, MD principal investigator
UZ Leuven Dept Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 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 29 Jan 2013. 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 Belgium. 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 Steven Pans (003216340505, steven.pans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of whole body diffusion weighted MRI in breastcancer patients (time frame: 6 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 29 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.