CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-pentixafor: All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).

PET/CT: PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies — Two years
  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.
• Concordance of [⁶⁸Ga]Ga-pentixafor PET/CT with Standard Clinical Staging Systems — Two years
  To evaluate the concordance between \[⁶⁸Ga\]Ga-pentixafor PET/CT-based staging and conventional clinical staging systems (e.g., Ann Arbor, Durie-Salmon PLUS, R-ISS/R2-ISS) in patients with hematological malignancies. Concordance will be measured using Cohen's kappa statistic (κ).
• Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Progression-Free Survival — Four years
  To assess whether imaging biomarkers from \[⁶⁸Ga\]Ga-pentixafor PET/CT, such as SUVmax or total lesion CXCR4 uptake, predict progression-free survival (PFS) in patients with hematological malignancies. Comparison will be made with \[¹⁸F\]FDG PET/CT-derived parameters.
• Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Overall Survival — Four years
  To evaluate whether \[⁶⁸Ga\]Ga-pentixafor PET/CT-based biomarkers can predict overall survival in patients with hematological malignancies, compared with \[¹⁸F\]FDG PET/CT.
• Dice Similarity Coefficient (DSC) for AI-based lesion segmentation — Two years
  Evaluation of the overlap between artificial intelligence-generated lesion segmentations and expert manual annotations on PET/CT images using the Dice similarity coefficient (DSC).

Trial sites (1)

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