Multiple MyelomaRAMPNCT03147326
Diagnostic Imaging of Myeloma Bone Lesions
A study testing FDG-PET-CT, NaF-PET-CT and Whole-body MRI in people with Multiple Myeloma, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- FDG-PET-CT, NaF-PET-CT and Whole-body MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed multiple myeloma (biopsy proven)
Who cannot join
- Prior malignancy
- Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker)
- Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent)
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Radiology/Department of Nuclear Medicine
Herlev, 2730
About this study
Official title: The Diagnostic Value of FDG-PET-CT, NaF-PET-CT and Whole-body MRI Compared to Whole-body Xray in the Detection of Bone Lesions in Multiple Myeloma Patients
The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.
Read the detailed description
Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival.
Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice.
Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions.
Endpoint is purely diagnostic.
Statistics:
Cochran's Q-test: to compare the proportion of patients with bone disease detected by the four scanning methods.
Two-sided ANOVA: to compare the average number of regions detected with bone disease by the four scanning methods.
Tukey's comparison test: to compare the difference between each pair of means.
- Conditions
- Multiple Myeloma
- Being tested
- FDG-PET-CT, NaF-PET-CT, Whole-body MRI
- 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-PET-CTDiagnostic test
scanning method
NaF-PET-CTDiagnostic test
scanning method
Whole-body MRIDiagnostic test
scanning method
| Study group | Role | What they receive |
|---|---|---|
| FDG-NaF-MRI | Other | All participants will undergo three project scans/the following interventions:
FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice. Receives: Diagnostic Test: FDG-PET-CT; Diagnostic Test: NaF-PET-CT; Diagnostic Test: Whole-body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone metastases detection rate - a patient-based analysis
To compare the proportion of patients with bone disease detected by the four scanning techniques
Measured: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
Bone metastases detection rate - a region-based analysis
To compare the number of affected regions with bone disease detected by the four scanning techniques
Measured: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startOct 2012
- Primary completionSep 2015
- Study completionApr 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Dyrberg Mortensen, Herlev Hospital
- Investigators
- Henrik S. Thomsen, Professor, Study director, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147326
- Sponsor's protocol ID
- RAMP
- Acronym
- RAMP
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of FDG-PET-CT, NaF-PET-CT and Whole-body MRI Compared to Whole-body Xray in the Detection of Bone Lesions in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT03147326
- Acronym / sponsor ID
- RAMP / RAMP
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 May 2017 (actual)
- 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 compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.
Detailed description
Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival.
Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice.
Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions.
Endpoint is purely diagnostic.
Statistics:
Cochran's Q-test: to compare the proportion of patients with bone disease detected by the four scanning methods.
Two-sided ANOVA: to compare the average number of regions detected with bone disease by the four scanning methods.
Tukey's comparison test: to compare the difference between each pair of means.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-NaF-MRI | Other | Diagnostic Test: FDG-PET-CT, Diagnostic Test: NaF-PET-CT, Diagnostic Test: Whole-body MRIAll participants will undergo three project scans/the following interventions: FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed multiple myeloma (biopsy proven)
Key exclusion criteria (4 listed)
- Prior malignancy
- Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker)
- Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent)
- Severe claustrophobia
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-PET-CTscanning method | Diagnostic test | FDG-NaF-MRI |
| NaF-PET-CTscanning method | Diagnostic test | FDG-NaF-MRI |
| Whole-body MRIscanning method | Diagnostic test | FDG-NaF-MRI |
Primary outcome
Bone metastases detection rate - a patient-based analysis
Time frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the proportion of patients with bone disease detected by the four scanning techniques
Bone metastases detection rate - a region-based analysis
Time frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the number of affected regions with bone disease detected by the four scanning techniques
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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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.
Henrik S. Thomsen, Professor study director
Department of Radiology
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-PET-CT, NaF-PET-CT and Whole-body MRI in people with Multiple Myeloma, run by Herlev Hospital at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 10 May 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Bone metastases detection rate - a patient-based analysis (time frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed). The study lists 2 primary outcomes in all. 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 10 May 2017.