Diagnostic Imaging of Myeloma Bone Lesions
RAMP
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
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started Oct 2012
Longer than P75 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedMay 10, 2017
May 1, 2017
2.9 years
April 25, 2017
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Bone metastases detection rate - a patient-based analysis
To compare the proportion of patients with bone disease detected by the four scanning techniques
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
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
Study Arms (1)
FDG-NaF-MRI
OTHERAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed multiple myeloma (biopsy proven)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Department of Radiology/Department of Nuclear Medicine
Herlev, 2730, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henrik S. Thomsen, Professor
Department of Radiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor, PhD-student
Study Record Dates
First Submitted
April 25, 2017
First Posted
May 10, 2017
Study Start
October 1, 2012
Primary Completion
September 1, 2015
Study Completion
April 1, 2017
Last Updated
May 10, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share