Clinical trial NCT03147326: Diagnostic Imaging of Myeloma Bone Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone metastases detection rate - a patient-based analysis
timeFrame: 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
measure: Bone metastases detection rate - a region-based analysis
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Radiology/Department of Nuclear Medicine
Study officials:
affiliation: Department of Radiology
name: Henrik S. Thomsen, Professor
role: STUDY_DIRECTOR
References: