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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan | Experimental | Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Pentixather | Drug | After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Huo, MD. | Contact | 86-10-69155537 | huoli@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiao Yang, MD. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000597686 | 68Ga-pentixafor |
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68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
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| 68Ga-Pentixafor | Drug | After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed. |
|
|
| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |