Multiple Myeloma
Conditions
Keywords
multiple myeloma, CXCR4, 68Ga-pentixather, PET/CT, 68Ga-pentixafor
Brief summary
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
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.
Interventions
DRUG68Ga-Pentixather
After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.
DRUG68Ga-Pentixafor
After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission 2. Signed written consent
Exclusion criteria
1. pregnancy 2. breastfeeding 3. known allergy against pentixather or pentixafor 4. any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET-positive extramedullary lesions | through study completion, an average of 2 years | Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. |
| Metabolic parameter | through study completion, an average of 2 years | Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. |
| PET-positive diffuse bone marrow involvement | through study completion, an average of 2 years | Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. |
| PET-positive focal bone marrow lesions | through study completion, an average of 2 years | Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | through study completion, an average of 2 years | Types of adverse events. |
| Tumor burden assessment | through study completion, an average of 2 years | The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging |
| Follow-up assessment | through study completion, an average of 2 years | The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS). |
| CXCR4 expression in biopsies and metabolic parameters in PET | through study completion, an average of 2 years | The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET. |
Countries
China
Contacts
Primary ContactLi Huo, MD.
Outcome results
None listed