68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma

Study Overview
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Brief Summary
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Chemokine receptor-4 (CXCR4) is overexpressed in multiple myeloma (MM) cells. 68Ga-pentixafor is a radio-labled tracer for CXCR4 . 68Ga-pentixafor PET/CT has shown good diagnostic performance in MM. But an exchange of Ga3+ by Lu3+ or Y3+ will lead to a significant loss of CXCR4 affinity. Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

Detailed Description
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Multiple myeloma (MM) is a malignant plasma cell disorder which is characterized by clonal proliferation of plasma cell in bone marrow microenvironment. Chemokine receptor-4 (CXCR4) is overexpressed in MM cells, and has been identified as a potential therapy target. 68Ga-pentixafor is a radiolabeled ligand with high affinity for CXCR4. 68Ga-pentixafor PET/CT has been reported with better diagnostic performance than 18F-FDG PET/CT. However, considering both diagnostic and therapeutic applications, an exchange of Ga3+ by other M3+ ions (Lu or Y) will lead to a significant loss of CXCR4 affinity. Thus, pentixather was developed as the precursor of 177Lu-pentixather or 90Y-pentixather, which can be used in CXCR4-targeted peptide receptor radionuclide therapy (PRRT). Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

Official Title
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Comparison of 68Ga-pentixather and 68Ga-pentixafor PET/CT in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: 68Ga-Pentixather
* Drug: 68Ga-Pentixafor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission Signed written consent Exclusion Criteria: pregnancy breastfeeding known allergy against pentixather or pentixafor any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan<br>Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval | Drug: 68Ga-Pentixather<br>* After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.<br>* Other names: 68Ga-Pentixather injection;Drug: 68Ga-Pentixafor<br>* After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.<br>* Other names: 68Ga-Pentixafor injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameter | Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. | through study completion, an average of 2 years | 
| PET-positive diffuse bone marrow involvement | Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. | through study completion, an average of 2 years | 
| PET-positive focal bone marrow lesions | Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. | through study completion, an average of 2 years | 
| PET-positive extramedullary lesions | Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Types of adverse events. | through study completion, an average of 2 years | 
| Tumor burden assessment | The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging | through study completion, an average of 2 years | 
| Follow-up assessment | The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS). | through study completion, an average of 2 years | 
| CXCR4 expression in biopsies and metabolic parameters in PET | The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET. | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CXCR4, multiple myeloma, 68Ga-pentixather, PET/CT, 68Ga-pentixafor