Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 16, 2020
Date Accepted: Jun 23, 2020
Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial
ABSTRACT
Background:
The International Myeloma Working Group recommends the use of 18-FDG Positron Emission Tomography/Computed-Tomography (FDG-PET) for treatment response evaluation, as it is superior to MRI. However, at initial staging, sensitivity of FDG-PET remains inferior to that of MRI. Therefore, there is a need for an imaging technique that could have sensitivity equal to MRI at diagnosis and also serve for therapy evaluation. 18F-Choline, has shown increased sensitivity as compared to 18-FDG with about 70% more lesions detected in MM patients with relapse or progressive disease. Our main objective is to prospectively compare, in newly diagnosed MM, the detection rate of bone lesions by 18F-Choline PET/CT (FCH-PET) and by FDG-PET. Our secondary objectives are: to assess the accuracy of both PET modalities for the detection of bone lesions and the diagnosis of diffuse disease; to assess the detection rate of extramedullary lesions.
Objective:
Objective:
Our main objective is to prospectively compare, in newly diagnosed MM, the detection rate of bone lesions by 18F-Choline PET/CT (FCH-PET) and by FDG-PET. Our secondary objectives are: to assess the accuracy of both PET modalities for the detection of bone lesions and the diagnosis of diffuse disease; to assess the detection rate of extramedullary lesions.
Methods:
Methods:
Thirty patients will be prospectively included in a paired comparative accuracy study. Patients with de novo MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks. Whole-body MRI will be composed of conventional sequences on spine and pelvis and of whole-body diffusion axial sequences. Six skeletal areas will be defined: skull, sternum/costal grid, spine, pelvis, superior limbs and inferior limbs. Number of focal lesions, their respective localization and intensity of uptake will be retrieved in each skeletal area. Reading will be performed blinded from other imaging techniques. Reference standard will be WB-MRI. Focal lesions present on PET/CT but not on whole-body MRI will require a decision made with a consensus of experts based on clinical and imaging data. Number of bone lesions and number of extramedullary lesions will be compared with Wilcoxon test. Accuracy of FCH-PET and FDG-PET will be compared with McNemar test.
Results:
The study started September 2019 and enrollment is ongoing. Four participants have been included. Data collection is expected to be completed in June 2021 and the results are expected to be available December 2021.
Conclusions:
Discussion: This study will assess if FCH-PET is superior to FDG-PET for the evaluation of MM tumor burden. This will pave the way for future prospective evaluations of the prognostic value of 18-FCH for treatment response evaluation in MM patients. Additionally, this work may open up new perspectives for better assessment of smoldering multiple myeloma risk of progression to MM. Clinical Trial: This study has been registered at ClinicalTrials.gov (NCT03891914) on March 29, 2019.
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