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NCT Number: NCT06871176

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

[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.

Other names: CXCR4

Primary outcomes

  1. Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging

    Time frame: Baseline (at initial staging)

    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.

Secondary outcomes

  1. Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire

    Time frame: Post-initial staging (before starting treatment)

    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.

  2. Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire

    Time frame: 3 months after start of participants therapy for MM

    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.

  3. Gather data to inform on patient selection for theranostics studies

    Time frame: Baseline (initial staging)

    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

  4. Monitoring for Adverse Events Related to Radiopharmaceutical Administration

    Time frame: 6 months (from baseline to final follow-up)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Veit-Haibach, MD

CONTACT

[email protected]

416-340-4800 Ext. 6085

Vishal Kukreti, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

[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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 11, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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