Clinical trial · Interventional
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
[68Ga]Pentixafor PET/CT for Staging of Hematological Malignancies: Comparison to [18F]FDG PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-Pentixafor and 18F-FDG PET/CT Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- before-after study in the same patient
- description
- 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.
- interventionNames
- Diagnostic Test: 68Ga-Pentixafor and 18F-FDG PET/CT Scan
Primary outcomes (3)
- measure
- Maximum Standardized uptake value (SUVmax)
- timeFrame
- 1 day from injection of the tracer
- description
- Maximum Standardized uptake value (SUVmax) of \[68Ga\]Pentixafor and \[18F\]FDG in the included subjects' primary and/or metastatic lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYu 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