Multiple myeloma is a disease mainly located in participants bones. Usually a participants physician arrives at this diagnosis by doing blood tests and ordering standard of care imaging tests (18F-FDG PET/CT and maybe additional MRI) to see how many bones (and/or other organs) are affected. While these two imaging tests are already very good, recent research indicates that even more precise imaging methods could be used to diagnose participants disease more precisely.
The purpose of this study is to learn if a combined PET/MR scan with a new radiotracer, \[68Ga\]Ga-PentixaFor, can provide more accurate and precise diagnostic information in patients with Multiple Myeloma, a type of cancer primarily affecting the bones.
This study aims to improve the accuracy of diagnosing and monitoring Multiple Myeloma using more advanced imaging techniques.
Patient older than 18 years of age
Clinical diagnosis of (nonsecretory, oligosecretory, suspicion for extramedullary MM) MM. MM diagnosis is based on IMWG (International Myeloma Working Group) criteria.No treatment received beyond first course of
Any contra-indications for MRI or 18F-FDG PET/CT imaging according to institutional guideline
Pregnancy (will be ruled out as per institutional protocol)
Inability to lie still in prone position in MRI for at least 30 min or PET/CT for at least 30 min
Patients or unwilling to use contraception during study and breastfeeding women can also not partake in this study
Single group
[68Ga]Ga-PentixaFor
Drug\[68Ga\]Ga-PentixaFor will be administered intravenously using the recommended activity for adults which is up to 150 MBq (4 mCi) fixed dose. There is no weight adaption recommended in the literature.
Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging
This primary outcome will assess the diagnostic accuracy of the CXCR4-targeted \[68Ga\]Ga-PentixaFor PET/MR imaging in comparison to the standard 18F-FDG PET/CT and MRI imaging in newly diagnosed multiple myeloma (MM) patients. Specifically, the focus will be on the number of bone marrow myeloma manifestations detected by CXCR4 PET/MR compared to standard imaging, as well as the number of extra-osseous myeloma manifestations detected.
Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
Using a questionnaire, the investigators aim to evaluate how hematologists make treatment decisions based on the addition of CXCR4 PET/MR imaging influences in MM patients, including adjustments in preconditioning, evaluation for radiotherapy, decisions for or against stem cell transplantation, and changes in follow-up schedules.
Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
Using a questionnaire, the investigators aim to evaluate how hematologist assess how the availability of CXCR4 PET/MR affects decisions during therapy response assessment. This could include changes in imaging follow-up, supportive therapy decisions, or additional evaluations.
Gather data to inform on patient selection for theranostics studies
The investigators will collect all data measurements on imaging and disease characteristics from CXCR4 imaging and standard-of-care imaging, integrating these findings to form a comprehensive assessment of whether patients may be suitable candidates for theranostic studies
Monitoring for Adverse Events Related to Radiopharmaceutical Administration
Document any adverse events following the administration of the radiopharmaceutical \[68Ga\]Ga-PentixaFor during PET/MR imaging, including any potential side effects or safety concerns.
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