PET/MR with a CXCR4 tracer versus standard PET/CT and MRI for initial staging and follow-up in multiple myeloma

[68Ga]Ga-PentixaFor (CXCR4) PET/MR for Initial Staging and Follow up in Multiple Myeloma: Prospective Comparison With Standard of Care PET/CT and Evaluation of Therapy Influence

This test will see if a PET/MR scan using a new tracer called [68Ga]Ga-PentixaFor finds multiple myeloma in bones more accurately than standard PET/CT and MRI for adults at diagnosis or follow-up.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06871176 on ClinicalTrials.gov

What this trial studies

This interventional study compares a combined PET/MR scan using the CXCR4-targeted tracer [68Ga]Ga-PentixaFor to standard 18F-FDG PET/CT and conventional MRI in people with multiple myeloma. Participants (adults, newly diagnosed or being evaluated around stem cell transplantation) will undergo both imaging approaches for initial staging and follow-up. Investigators will compare lesion detection, diagnostic accuracy, prognostic information, and the frequency with which imaging influences treatment decisions. The aim is to see whether CXCR4 PET/MR gives more precise disease mapping and could reduce the need for multiple separate imaging sessions.

Who should consider this trial

Good fit: Adults (18+) with a clinical diagnosis of multiple myeloma—including nonsecretory, oligosecretory, or suspected extramedullary disease—who are newly diagnosed or undergoing staging/follow-up and can tolerate MRI and PET/CT are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, unable to lie still for imaging, have contraindications to MRI or PET/CT or known allergy to the tracer components, or have another active hematologic malignancy are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this imaging approach could detect bone and extramedullary myeloma more precisely, improve staging and treatment planning, and reduce the number of separate scans patients need.

How similar studies have performed: CXCR4-targeted PET imaging such as [68Ga]Ga-PentixaFor is a relatively new but promising approach with preliminary studies showing improved lesion detection in some myeloma patients, though it is not yet as widely validated as 18F-FDG PET/CT.

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)

Where this trial is running

Toronto, Ontario

• University Health Network — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Patrick Veit-Haibach, MD — University Health Network, Toronto
• Study coordinator: Patrick Veit-Haibach, MD

Conditions: Multiple Myeloma