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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-Pentixafor and 18F-FDG PET/CT Scan.
- Who it may be relevant to
- Registry conditions: Hematological Malignancies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
[68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT
Overview
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 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:
Primary outcome measures
- Maximum Standardized uptake value (SUVmax) [Time frame: 1 day from injection of the tracer]
- Mean Standardized Uptake Value(SUVmean) of liver [Time frame: 1 day from injection of the tracer]
- Mean Standardized uptake value (SUVmean) [Time frame: 1 day from injection of the tracer]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University — Xi'an
Publications
- Yu X, Tang H, Ou H, Quan Z, Li G, Gao G, Wang J, Kang F. Establishment and validation of a clinical threshold criteria for choosing PET imaging tracers for indolent non-Hodgkin's lymphoma. EJNMMI Res. 2025 Dec 27;16(1):17. doi: 10.1186/s13550-025-01368-7. PMID 41455028
Identifiers
NCT: NCT06834412 · KY20212119-F-1 · KY20212119-F-1