Hematological Malignancies
Conditions
Keywords
68Ga-Pentixafor, hematological malignancies, 18F-FDG, staging
Brief 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.
Interventions
DIAGNOSTIC_TEST68Ga-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.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
before-after study in the same patient
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Ages 18 to 75 years old Confirmed by pathology with NHLs or myeloma Willing and able to follow the study protocol.
Exclusion criteria
Children, pregnant or lactating women Severely impaired liver and kidney function (alanine aminotransferase \> 8-10 times the upper limit of normal, serum creatinine 186-442 umol/L) With a history of allergy to contrast media or other drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYing Guo
Backup ContactXuebing Yu
Outcome results
None listed