CXCR4-targeted PET/CT Imaging in Hematological Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorZhongnan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Volunteer to participate and sign an informed consent form;
18 ≤ Age ≤ 90 years;
Patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies;
Willing and able to follow schedule visits, treatment plans and laboratory tests.
Disqualifiers
pregnancy or breastfeeding;
Allergic to CXCR4-targeted tracers or excipients;
Fasting blood glucose level exceeded 11.0 mmol/L prior to injection of 18F-FDG;
Those who cannot complete PET/CT scan, including inability to keep supine, claustrophobia, radiation phobia, etc.;
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-pentixafor
DrugAll participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).
PET/CT
DevicePET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: 68Ga-pentixafor and 18F-FDG PET/CTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
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.
Time frame
Two years2
Concordance of [⁶⁸Ga]Ga-pentixafor PET/CT with Standard Clinical Staging Systems
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).
Time frame
Two years3
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Progression-Free Survival
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.
Time frame
Four years4
Predictive Value of [⁶⁸Ga]Ga-pentixafor PET/CT Parameters for Overall Survival
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.
Time frame
Four yearsSecondary outcomes
1
Correlation Between CXCR4 Expression and [⁶⁸Ga]Ga-pentixafor PET/CT Parameters
To assess the correlation between CXCR4 expression levels in biopsy samples and semiquantitative parameters from \[⁶⁸Ga\]Ga-pentixafor PET/CT (e.g., SUVmax).
Time frame
Two years2
Correlation between del(17p) status and TLU on [68Ga]Ga-pentixafor PET/CT
To assess the correlation between the presence or absence of del(17p), as identified by fluorescence in situ hybridization (FISH), and total lesion uptake (TLU) on \[68Ga\]Ga-pentixafor PET/CT at baseline. The degree of correlation will be measured using the Spearman correlation coefficient (rho), a unitless value ranging from -1 to +1.
Time frame
Two years3
Radiogenomic Model for Risk Prediction Using AI
To develop and validate an AI-based radiogenomic model integrating PET imaging features and genomic data to predict disease aggressiveness in patients with hematological malignancies.
Time frame
Two yearsSponsors and contacts
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Source ClinicalTrials.gov