Clinical trial NCT03891914: Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma
Official title: Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myeloma Multiple
Keywords: Multiple Myeloma
PET/CT
18F-FDG
18F-FCH
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 30
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: Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Symptomatic Multiple Myeloma on first-line treatment as defined by 2014 International Myeloma Working Group criteria
* Measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay
* Age \> 18 years old at time of signed consent
* Beneficiary of social security insurance
* Signed informed consent

Exclusion Criteria:

* Previous Multiple Myeloma treatment
* Previous cancer with less than 5 year of complete remission (including plasmacytoma)
* Chemotherapy in the 6 months preceding the inclusion
* Uncontrolled diabetes mellitus
* Medullary growth factor injection less than 48 hours before imaging procedures
* Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging
* Pregnant or nursing (lactating) women
* Childbearing potential woman without adequate barrier contraception method (HAS criteria)
* Freedom deprivated patient by judiciary or administrative decision
* Patient under legal protection or unable to express its own consent
* PET contraindication (known allergy to 18F-FCH or 18F-FDG or excipient)
* MRI contraindication

Primary outcomes:
measure: Number of whole-body bone lesions
timeFrame: Day 0
measure: Number of whole-body bone lesions
timeFrame: Day 7
measure: Number of bone lesions within defined skeletal areas
timeFrame: Day 0
measure: Number of bone lesions within defined skeletal areas
timeFrame: Day 7
Secondary outcomes:
measure: Diagnostic performance for the detection of focal bone lesions
timeFrame: Day 0
measure: Diagnostic performance for the detection of focal bone lesions
timeFrame: Day 7
measure: Diagnostic performances for the detection of diffuse infiltrative disease of the spine
timeFrame: Day 7
measure: Diagnostic performances for the detection of diffuse infiltrative disease of the spine
timeFrame: Day 0
measure: Number of extra-medullary lesions
timeFrame: Day 7
measure: Number of extra-medullary lesions
timeFrame: Day 0
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital - Haut-Lévêque
Study officials:
References:
citation: Mesguich C, Hulin C, Latrabe V, Asselineau J, Bordenave L, Perez P, Hindie E, Marit G. 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. JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.