Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2012-10-31
2017-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FDG-NaF-MRI
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.
FDG-PET-CT
scanning method
NaF-PET-CT
scanning method
Whole-body MRI
scanning method
Interventions
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FDG-PET-CT
scanning method
NaF-PET-CT
scanning method
Whole-body MRI
scanning method
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Eva Dyrberg Mortensen
Medical doctor, PhD-student
Principal Investigators
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Henrik S. Thomsen, Professor
Role: STUDY_DIRECTOR
Department of Radiology
Locations
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Department of Radiology/Department of Nuclear Medicine
Herlev, , Denmark
Countries
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Other Identifiers
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RAMP
Identifier Type: -
Identifier Source: org_study_id
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