Multiple MyelomaNCT01780766
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
An observational study of Multiple Myeloma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Whole body MRI with diffusion weighted imaging is a useful imaging tool staging and diagnosis therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Sep 2014
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical and laboratory findings, highly suggestive for multiple myeloma. All patients underwent bone marrow biopsy.
Who may be able to join
- Patients with clinical and laboratory findings, highly suggestive for multiple myeloma.
Who cannot join
- All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven
Steven Pans, MD, 3216340505, steven.pans@uzleuven.be
About this study
Official title: Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up
Whole body MRI with diffusion weighted imaging is a useful imaging tool
- staging and diagnosis
- therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).
- Conditions
- Multiple Myeloma
- Keywords
- Whole body MRI, Multiple myeloma, Diffusion Weighted MRI, Whole body scan
- Medical subject headings
- Multiple Myeloma
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 |
|---|---|---|
| Indolent myeloma patient | Not described | |
| Symptomatic Myeloma patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation
Validation of whole body MRI diffusion-weighted imaging in multiple myeloma at 3 Tesla MRI: correlation of the new MRI imaging technique (diffusion weighted imaging)to standard validated imaging technique (Computer Tomography and Magnetic Resonance Imaging)
Measured: 2 years
Secondary outcomes (1)
Therapy assessment
Whole body MRI with Diffusion weighted imaging is useful for treatment monitoring in multiple myeloma patients during and after therapy.
Measurement of apparent diffusion coefficient (ADC) and comparison of ADC before, during and after therapy. Correlation of ADC with clinical findings and standard MRI findings.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startSep 2008
- Primary completionMar 2013 (estimated)
- Study completionSep 2014 (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 Multiple MyelomaStudies 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
- 100 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, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780766
- Sponsor's protocol ID
- FIMM
- Other IDs
- S51079
- Status last verified
- Jan 2013
- First submitted
- 26 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bannas P, Hentschel HB, Bley TA, Treszl A, Eulenburg C, Derlin T, Yamamura J, Adam G, Stubig T, Kroger N, Weber C. Diagnostic performance of whole-body MRI for the detection of persistent or relapsing disease in multiple myeloma after stem cell transplantation. Eur Radiol. 2012 Sep;22(9):2007-12. doi: 10.1007/s00330-012-2445-y. Epub 2012 Apr 29.
PubMed 22544292
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up
- ClinicalTrials.gov ID
- NCT01780766
- Acronym / sponsor ID
- FIMM
- Conditions
- Multiple Myeloma
- Keywords
- Whole body MRI, Multiple myeloma, Diffusion Weighted MRI, Whole body scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 31 Jan 2013 (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.
Whole body MRI with diffusion weighted imaging is a useful imaging tool
- staging and diagnosis
- therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indolent myeloma patient | – | – |
| Symptomatic Myeloma patient | – | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical and laboratory findings, highly suggestive for multiple myeloma. All patients underwent bone marrow biopsy.
Key inclusion criteria (1 listed)
- Patients with clinical and laboratory findings, highly suggestive for multiple myeloma.
Key exclusion criteria (1 listed)
- All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)
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
Time frame: 2 years
Validation of whole body MRI diffusion-weighted imaging in multiple myeloma at 3 Tesla MRI: correlation of the new MRI imaging technique (diffusion weighted imaging)to standard validated imaging technique (Computer Tomography and Magnetic Resonance Imaging)
1 secondary outcome
Therapy assessment
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Background: PubMed 22544292Bannas P, Hentschel HB, Bley TA, Treszl A, Eulenburg C, Derlin T, Yamamura J, Adam G, Stubig T, Kroger N, Weber C. Diagnostic performance of whole-body MRI for the detection of persistent or relapsing disease in multiple myeloma after stem cell transplantation. Eur Radiol. 2012 Sep;22(9):2007-12. doi: 10.1007/s00330-012-2445-y. Epub 2012 Apr 29.
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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
Universitaire Ziekenhuizen KU Leuven
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 Multiple Myeloma, 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 1 inclusion and 1 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 31 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, MD (3216340505, 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 (time frame: 2 years). 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 NCT01780766, 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 31 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.