A Study Evaluating the Value of 68Ga-Pentixafor PET Imaging in the Staging of Hematological Tumor, and Comparing It with 18F-FDG PET/CT Imaging

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-Pentixafor and 18F-FDG PET/CT Scan: The imaging agent 68Ga-Pentixafor and 18F-FDG used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is about 4; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185\~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.

Study summary

This is a prospective, open-label, single-center clinical study targeting hematological malignancies. 120 patients with a confirmed by pathology of non-Hodgkin's lymphoma or myeloma were included. Qualified subjects will undergo 18F-FDG PET/CT and 68Ga-Pentixafor PET/CT examination. The aim is to To investigate whether 68Ga-pentixafor PET imaging can be used as a reliable complement to 18F-FDG PET imaging for clinical staging, treatment response evaluation, and re-staging of patients with hematological malignancies.

Eligibility

Primary outcome measure(s)

• Maximum Standardized uptake value (SUVmax) — 1 day from injection of the tracer
  Maximum Standardized uptake value (SUVmax) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.
• Mean Standardized Uptake Value(SUVmean) of liver — 1 day from injection of the tracer
  Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.
• Mean Standardized uptake value (SUVmean) — 1 day from injection of the tracer
  Mean Standardized uptake value (SUVmean) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.

Trial sites (1)

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