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| ID | Type | Description | Link |
|---|---|---|---|
| KY20212119-F-1 | Other Identifier | medical ethics committee of the Xijing hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| before-after study in the same patient | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Pentixafor and 18F-FDG PET/CT Scan | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 day from injection of the tracer |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Guo | Contact | 0086+15991459177 | guoying01192022@163.com | |
| Xuebing Yu | Contact | 0086+18967285780 | 786979204@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41455028 | Derived | 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. |
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before-after study in the same patient
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|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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