Multiple Myeloma
Conditions
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.
Interventions
\[68Ga\]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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire | 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. |
| Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire | 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. |
| Gather data to inform on patient selection for theranostics studies | 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 |
| Monitoring for Adverse Events Related to Radiopharmaceutical Administration | 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. |
Countries
Canada
Contacts
Primary ContactPatrick Veit-Haibach, MD
Backup ContactVishal Kukreti, MD
Outcome results
None listed