PMID- 32909953 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201010 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 9 IP - 9 DP - 2020 Sep 10 TI - Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial. PG - e17850 LID - 10.2196/17850 [doi] LID - e17850 AB - BACKGROUND: The International Myeloma Working Group recommends the use of 18-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) for treatment response evaluation, as it is superior to magnetic resonance imaging (MRI). However, at initial staging, the sensitivity of FDG-PET remains inferior to that of MRI. Therefore, there is a need for an imaging technique that could have a sensitivity equal to that of MRI at diagnosis and could serve to evaluate therapy. 18F-choline has shown increased sensitivity when compared with 18-FDG, with about 75% more lesions detected in patients with relapsed or progressive multiple myeloma (MM). OBJECTIVE: Our primary objective is to prospectively compare the detection rate of bone lesions by 18F-choline PET/CT (FCH-PET) and FDG-PET in newly diagnosed MM. 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: We will prospectively include 30 patients in a paired comparative accuracy study. Patients with de novo MM will undergo FCH-PET, FDG-PET, and whole-body MRI (WB-MRI) within a 3-week period. WB-MRI will be composed of conventional sequences on the spine and pelvis and of whole-body diffusion axial sequences. The following 6 skeletal areas will be defined: skull, sternum/costal grid, spine, pelvis, superior limbs, and inferior limbs. The number of focal lesions, their respective localization, and intensity of uptake will be retrieved for each skeletal area. Readings will be performed blinded from other imaging techniques. The reference standard will be WB-MRI. Focal lesions present on PET/CT but not on WB-MRI will require a decision made with a consensus of experts based on clinical and imaging data. The number of bone lesions and number of extramedullary lesions will be compared using the Wilcoxon test. The accuracy of FCH-PET and FDG-PET will be compared using the McNemar test. RESULTS: The study started in September 2019, and enrollment is ongoing. As of June 2020, 8 participants have been included. Data collection is expected to be completed in June 2021, and the results are expected to be available in December 2021. CONCLUSIONS: 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 provide new perspectives for better assessment of the risk of smoldering MM progressing to MM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03891914; https://clinicaltrials.gov/ct2/show/NCT03891914. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17850. CI - (c)Charles Mesguich, Cyrille Hulin, Valerie Latrabe, Julien Asselineau, Laurence Bordenave, Paul Perez, Elif Hindie, Gerald Marit. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.09.2020. FAU - Mesguich, Charles AU - Mesguich C AUID- ORCID: 0000-0002-3889-755X AD - Nuclear Medicine Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. AD - INSERM U1035, Universite de Bordeaux, Bordeaux, France. FAU - Hulin, Cyrille AU - Hulin C AUID- ORCID: 0000-0002-3749-5161 AD - Hematology Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Latrabe, Valerie AU - Latrabe V AUID- ORCID: 0000-0001-6686-6403 AD - Radiology Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Asselineau, Julien AU - Asselineau J AUID- ORCID: 0000-0003-1893-2730 AD - Clinical Epidemiology Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Bordenave, Laurence AU - Bordenave L AUID- ORCID: 0000-0001-8212-0740 AD - Nuclear Medicine Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Perez, Paul AU - Perez P AUID- ORCID: 0000-0001-7543-3810 AD - Clinical Epidemiology Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Hindie, Elif AU - Hindie E AUID- ORCID: 0000-0003-2101-5626 AD - Nuclear Medicine Department, Centre Hospitalier Universitaire de Bordeaux, Pessac, France. FAU - Marit, Gerald AU - Marit G AUID- ORCID: 0000-0001-9924-8636 AD - INSERM U1035, Universite de Bordeaux, Bordeaux, France. LA - eng SI - ClinicalTrials.gov/NCT03891914 PT - Journal Article DEP - 20200910 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC7516691 OTO - NOTNLM OT - 18-FDG OT - 18F-choline OT - MRI OT - PET/CT OT - cancer OT - medical imaging OT - multiple myeloma OT - skeletal system COIS- Conflicts of Interest: Curium Pharma graciously provided 20 doses of 18F-choline. EDAT- 2020/09/11 06:00 MHDA- 2020/09/11 06:01 PMCR- 2020/09/10 CRDT- 2020/09/10 12:24 PHST- 2020/01/16 00:00 [received] PHST- 2020/06/23 00:00 [accepted] PHST- 2020/06/17 00:00 [revised] PHST- 2020/09/10 12:24 [entrez] PHST- 2020/09/11 06:00 [pubmed] PHST- 2020/09/11 06:01 [medline] PHST- 2020/09/10 00:00 [pmc-release] AID - v9i9e17850 [pii] AID - 10.2196/17850 [doi] PST - epublish SO - JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.