Clinical trial NCT06871176: PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-arm, controlled, comparative study. Participants with newly diagnosed multiple myeloma will undergo both standard imaging (18F-FDG-PET/CT and MRI) and the investigational \[68Ga\]Ga-PentixaFor (CXCR4) PET/MR imaging. The study will assess the diagnostic accuracy and potential therapeutic influence of the CXCR4 PET/MR scan in comparison to the standard of care. The study will include both initial staging and follow-up imaging assessments, with an emphasis on how the new imaging modality influences treatment decisions.
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging
timeFrame: Baseline (at initial staging)
Secondary outcomes:
measure: Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
timeFrame: Post-initial staging (before starting treatment)
measure: Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
timeFrame: 3 months after start of participants therapy for MM
measure: Gather data to inform on patient selection for theranostics studies
timeFrame: Baseline (initial staging)
measure: Monitoring for Adverse Events Related to Radiopharmaceutical Administration
timeFrame: 6 months (from baseline to final follow-up)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Patrick Veit-Haibach, MD
role: PRINCIPAL_INVESTIGATOR
References: