RECRUITING Not applicable ClinicalTrials.gov

PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)

Sponsor: University Health Network, Toronto • ClinicalTrials.gov ID: NCT06871176

Registry updated: 2026-10-01

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Description

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.

Interventions

[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.

Eligibility criteria

Inclusion criteria * 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 Exclusion criteria * 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 * Inability to provide consent * Any hypersensitivity or known allergy to any component of the investigational product (\[68Ga\]Ga-PentixaFor)No concomitant other malignant hemato-oncological disease being diagnosed (i.e. additional lymphoma or leukemia)

Conditions

Multiple Myeloma

Locations

University Health Network — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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