Multiple MyelomaNCT00200668
Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
A study testing FDG = fluorodeoxyglucose in people with Multiple Myeloma, run by Nantes University Hospital at 1 site in France.
Trial summary
Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- FDG = fluorodeoxyglucose
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Dec 2006
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 65 years old.
- De novo histologically proven multiple myeloma.
Who cannot join
- No history of another cancer or of HIV
- No history of renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.
Read the detailed description
First whole body FDG-PET scan and MRI before the start of the treatment. Second whole body FDG-PET scan and MRI after the end of the treatment. On a basis of patient, comparison between PET and MRI will be done tumoral site by site. Sensitivity, Specificity will be estimated for both techniques. In case of discrepancy, another imaging method or biopsy (if easy to perform) will be serve as standard of reference. Kappa coefficients and Mc Nemar test will be performed to compare the two methods. FDG = fluorodeoxyglucose FLUCIS® (Schering-CisBio® international)
- Conditions
- Multiple Myeloma
- Being tested
- FDG = fluorodeoxyglucose
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG = fluorodeoxyglucoseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Couturier, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200668
- Sponsor's protocol ID
- BRD/04/6-H
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 9 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple Myeloma Patients.
- ClinicalTrials.gov ID
- NCT00200668
- Acronym / sponsor ID
- BRD/04/6-H
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (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.
Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.
Detailed description
First whole body FDG-PET scan and MRI before the start of the treatment. Second whole body FDG-PET scan and MRI after the end of the treatment. On a basis of patient, comparison between PET and MRI will be done tumoral site by site. Sensitivity, Specificity will be estimated for both techniques. In case of discrepancy, another imaging method or biopsy (if easy to perform) will be serve as standard of reference. Kappa coefficients and Mc Nemar test will be performed to compare the two methods. FDG = fluorodeoxyglucose FLUCIS® (Schering-CisBio® international)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients from 18 to 65 years old.
- De novo histologically proven multiple myeloma.
Key exclusion criteria (2 listed)
- No history of another cancer or of HIV
- No history of renal failure
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 |
|---|---|---|
| FDG = fluorodeoxyglucose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
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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.
Olivier Couturier, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG = fluorodeoxyglucose in people with Multiple Myeloma, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 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 1 site in France. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Jun 2008.