68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma
- Registration Number
- NCT05364177
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission
- Signed written consent
- pregnancy
- breastfeeding
- known allergy against pentixather or pentixafor
- any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan 68Ga-Pentixather Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan 68Ga-Pentixafor Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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).
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China