NCT06871176

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

[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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigators will be focusing on Multiple Myeloma patients, a disease mainly located in the participants bones. The goal of this clinical trial is to evaluate the diagnostic and prognostic value of CXCR4-targeted PET/MR imaging in patients with Multiple Myeloma (MM), comparing it to the standard 18F-FDG-PET/CT and MRI imaging for the initial staging, follow-up, and treatment decision-making. The study will focus on newly diagnosed MM patients and those who may undergo stem cell transplantation. The investigators will compare the performance of \[68Ga\]Ga-PentixaFor PET/MR to standard imaging methods (18F-FDG-PET/CT and MRI) to see if CXCR4-targeted imaging offers improved accuracy, better tumor detection, and a greater influence on treatment decisions. This study aims to establish whether combining CXCR4-targeted PET/MR imaging could become a comprehensive diagnostic tool for MM, enhancing disease monitoring, guiding therapeutic decisions, and reducing patient burden by eliminating the need for multiple imaging sessions.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-PentixaFor	\[68Ga\]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.

Timeline

• Start date: 2025-04-22
• Primary completion: 2028-03-04
• Completion: 2028-03-04
• First posted: 2025-03-11
• Last updated: 2025-06-25

Locations

1 site across 1 country: Canada