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

NCT ID: NCT06871176

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2028-03-04

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging

This arm involves patients undergoing the investigational imaging modality, CXCR4-targeted \[68Ga\]Ga-PentixaFor PET/MR, to evaluate its diagnostic, prognostic, and therapeutic value in comparison to standard imaging methods.

Group Type: EXPERIMENTAL

[68Ga]Ga-PentixaFor

Intervention Type: 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.

Interventions

[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.

Intervention Type: DRUG

Other Intervention Names

CXCR4

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Veit-Haibach, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Patrick Veit-Haibach, MD

Role: CONTACT

Patrick.Veit-Haibach@uhn.ca

416-340-4800 Ext. 6085

Vishal Kukreti, MD

Role: CONTACT

vishal.kukreti@uhn.ca

Other Identifiers

23-5828

Identifier Type: -

Identifier Source: org_study_id