Diagnostic Imaging of Myeloma Bone Lesions

Multiple Myeloma Clinical Trial

— RAMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147326
• Other study ID #: RAMP
• Status: Completed
• Phase: N/A
• First received: April 25, 2017
• Last updated: May 8, 2017
• Start date: October 2012
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed multiple myeloma (biopsy proven)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• FDG-PET-CT
scanning method
• NaF-PET-CT
scanning method
• Whole-body MRI
scanning method

Locations

Country	Name	City	State
Denmark	Department of Radiology/Department of Nuclear Medicine	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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