Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

Study Overview
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Brief Summary
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Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM and lymphoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM and lymphoma.

Detailed Description
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Multiple myeloma: Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The Durie and Salmon and ISS clinical staging system have been well-accepted as a practical way to evaluate MM tumor burden nowadays. But it is difficult to assess the accurate tumor involvement because of the significant heterogeneity characterizing this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome. New imaging modalities such as 18F-FDG PET/CT has been used to improve the efficacy of this system in assessing the extent and severity of MM, but the diagnostic accuracy of 18F-FDG PET/CT decreased in lower proliferative MM cells and inflammation. Recent studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM. Lymphoma: Lymphoma is a frequent cancer with high CXCR4 expression. According to the previous studies, 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis，differentiation and pretherapeutic evaluation of CXCR4 expression in lymphoma.

Official Title
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Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

Conditions
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Multiple Myeloma, Lymphoma

Intervention / Treatment
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* Drug: 68Ga-Pentixafor


Participation Criteria
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Eligibility Criteria
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Inclusion criteria： suspected or confirmed untreated MM or lymphoma patients 18F-FDG PET/CT within two weeks signed written consent. Exclusion criteria: pregnancy breastfeeding known allergy against 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-Pentixafor, PET/CT<br>Inject 68Ga-Pentixafor and then perform PET/CT scan. | Drug: 68Ga-Pentixafor<br>* Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga-Pentixafor will be used to image lesions of MM and lymphoma by PET/CT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease. | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value | Diagnostic value of 68Ga-Pentixafor PET/CT for MM and lymphoma in comparison with 18F-FDG PET/CT. | through study completion, an average of 2 years | 
| Incidence of emergency events during the study | Incidence of emergency events during the study | through study completion, an average of 2 years | 
| Tumor burden assessement | Correlation between tumor burden assessed on 68Ga-Pentixafor PET/CT and the DS and ISS clinical staging system for MM. | through study completion, an average of 2 years | 
| Diagnostic value in special type of multiple myeloma | Diagnostic value of 68Ga-Pentixafor PET/CT in monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) from symptomatic MM. | through study completion, an average of 2 years | 
| CXCR4 expression and SUV | Correlation between CXCR4 expression and SUV in PET | through study completion, an average of 2 years | 
| Overall Survival | analysis of OS for patients receiving 68Ga-Pentixafor PET/CT | 1 year and 5 years after been diagnosed | 
| Disease Free Survival | analysis of DFS for patients receiving 68Ga-Pentixafor PET/CT | 1 year and 5 years after been diagnosed | 
| Disease Specific Survival | analysis of DSS for patients receiving 68Ga-Pentixafor PET/CT | 1 year and 5 years after been diagnosed |