Clinical trial · Interventional
CXCR4-targeted PET/CT Imaging in Hematological Malignancies
An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
- 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)
Hematological malignancies continue to pose significant clinical challenges due to their high incidence, heterogeneous biology, and substantial mortality. Although 18F-FDG PET/CT remains the most commonly used molecular imaging modality, its limited specificity can result in false-positive or false-negative findings, especially in indolent or low-metabolism subtypes, thereby hampering accurate diagnosis, staging, and therapeutic evaluation. C-X-C chemokine receptor type 4 (CXCR4) is frequently overexpressed in a broad spectrum of hematologic malignancies and correlates with aggressive disease and unfavorable outcomes. CXCR4-targeted molecular imaging using \^68Ga-pentixafor PET/CT has shown promise for improved disease characterization. This prospective study aims to systematically compare 68Ga-pentixafor PET/CT with 18F-FDG PET/CT in terms of diagnostic performance, staging accuracy, risk stratification, and prognostic relevance in patients with hematological malignancies. Furthermore, the study will incorporate artificial intelligence-based image analysis to enhance lesion detection, automate quantitative assessments, and support personalized clinical decision-making.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CXCR4 | — | UNRESOLVED | — |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-pentixafor | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-pentixafor and 18F-FDG PET/CT
- description
- Patients with a high clinical suspicion of, or confirmed newly diagnosed or relapsed hematological malignancies will be recruited. All enrolled patients will undergo both 68Ga-pentixafor and 18F-FDG PET/CT imaging within two weeks.
- interventionNames
- Drug: 68Ga-pentixafor
- Device: PET/CT
Primary outcomes (5)
- measure
- Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
- timeFrame
- Two years
- description
- To assess and compare the diagnostic accuracy of 68Ga-pentixafor PET/CT and 18F-FDG PET/CT in patients with newly diagnosed, relapsed, or highly suspected hematological malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to participate and sign an informed consent form; 2. 18 ≤ Age ≤ 90 years; 3. Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies; 4. Willing and able to follow schedule visits, treatment plans and laboratory tests. Exclusion Criteria: 1. pregnancy or breastfeeding; 2. Allergic to CXCR4-targeted tracers or excipients; 3. Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG; 4. Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.; 5. Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
References
Publications (4)
- BACKGROUNDHerrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19. PMID 25698782
- BACKGROUNDPan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27. PMID 31776631
- BACKGROUNDDuell J, Krummenast F, Schirbel A, Klassen P, Samnick S, Rauert-Wunderlich H, Rasche L, Buck AK, Wester HJ, Rosenwald A, Einsele H, Topp MS, Lapa C, Kircher M. Improved Primary Staging of Marginal-Zone Lymphoma by Addition of CXCR4-Directed PET/CT. J Nucl Med. 2021 Oct;62(10):1415-1421. doi: 10.2967/jnumed.120.257279. Epub 2021 Feb 12. PMID 33579803
- DERIVEDChen J, Tang S, Liu L, Tian Y, Wang Y, Xiao Z, Xing D, Zhou F, Li C, He Y. [68Ga]Ga-Pentixafor PET/CT for Durie-Salmon PLUS staging and risk stratification in newly diagnosed multiple myeloma. Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4572-4586. doi: 10.1007/s00259-026-07813-6. Epub 2026 Feb 28. PMID 41760826