Diagnostic Imaging of Myeloma Bone Lesions (RAMP)

Herlev Hospital

Status: Completed

Conditions: Multiple Myeloma

Treatments: Diagnostic Test: Whole-body MRI; Diagnostic Test: FDG-PET-CT; Diagnostic Test: NaF-PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03147326

RAMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

FDG-NaF-MRI

Other group

Description:

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.

Treatment:

Diagnostic Test: Whole-body MRI

Diagnostic Test: FDG-PET-CT

Diagnostic Test: NaF-PET-CT