An Early Phase 1 interventional study of 68Ga-Pentixafor in Multiple Myeloma and Lymphoma, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Diagnostic
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.
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.
Exclusion criteria:
Inject 68Ga-Pentixafor and then perform PET/CT scan.
Drug: 68Ga-Pentixafor
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.
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.
Time frame: through study completion, an average of 2 years
Diagnostic value
Diagnostic value of 68Ga-Pentixafor PET/CT for MM and lymphoma in comparison with 18F-FDG PET/CT.
Time frame: through study completion, an average of 2 years
Incidence of emergency events during the study
Incidence of emergency events during the study
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 2 years
CXCR4 expression and SUV
Correlation between CXCR4 expression and SUV in PET
Time frame: through study completion, an average of 2 years
Overall Survival
analysis of OS for patients receiving 68Ga-Pentixafor PET/CT
Time frame: 1 year and 5 years after been diagnosed
Disease Free Survival
analysis of DFS for patients receiving 68Ga-Pentixafor PET/CT
Time frame: 1 year and 5 years after been diagnosed
Disease Specific Survival
analysis of DSS for patients receiving 68Ga-Pentixafor PET/CT
Time frame: 1 year and 5 years after been diagnosed
Plan to share: No
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Peking Union Medical College Hospital