An interventional study of 68Ga-Pentixafor and 18F-FDG PET/CT Scan in Hematological Malignancies, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Diagnostic
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
This is a prospective, open-label, single-center clinical study for hematological malignancies. 120 patients confirmed by pathology of having NHLs or myeloma were included. Qualified subjects underwent 18F-FDG and 68Ga-Pentixafor PET/CT scans within 7 days after recruited. Patient medical history was collected and laboratory tests were performed before the examination, and a biopsy or surgery was performed to obtain pathological results within 1 month after the examination, followed by a 6-month follow-up. The pathological results were used as the diagnostic gold standard.
Diagnostic Test: 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.
Maximum Standardized uptake value (SUVmax)
Maximum Standardized uptake value (SUVmax) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.
Time frame: 1 day from injection of the tracer
Mean Standardized Uptake Value(SUVmean) of liver
Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.
Time frame: 1 day from injection of the tracer
Mean Standardized uptake value (SUVmean)
Mean Standardized uptake value (SUVmean) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.
Time frame: 1 day from injection of the tracer
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xijing Hospital