An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
研究概览
简要总结
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.
详细描述
Hematological malignancies encompass a heterogeneous group of neoplasms originating from the bone marrow and lymphatic system. Despite advances in therapeutic strategies, the prognosis for many subtypes remains suboptimal, and accurate initial evaluation is critical for appropriate treatment planning. ^18F-FDG PET/CT is routinely used for functional imaging in these patients; however, its diagnostic utility is limited by variable glucose metabolism across disease subtypes and inflammatory uptake, which can lead to misclassification.
CXCR4, a chemokine receptor involved in tumor proliferation, invasion, and microenvironmental interactions, is overexpressed in numerous hematologic malignancies and has emerged as a molecular target for both imaging and therapy. 68Ga-pentixafor, a CXCR4-targeted PET radiotracer, has demonstrated superior lesion detection in preliminary studies, particularly in diseases with low 18F-FDG avidity.
This prospective study will investigate the clinical utility of 68Ga-pentixafor PET/CT in patients with newly diagnosed or relapsed hematological malignancies. Comparative analyses with 18F-FDG PET/CT will be performed to assess concordance, staging accuracy, and association with known risk stratification systems. Longitudinal follow-up will be conducted to evaluate the prognostic relevance of imaging findings.
In parallel, the study will explore the application of artificial intelligence (AI) techniques, including deep learning-based image segmentation and radiomic feature extraction, to enhance diagnostic precision and support risk-adapted management strategies. AI-driven models will be developed and validated to predict disease burden, progression, and survival, thereby contributing to personalized medicine in hematologic oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.;
- •Researchers think it is inappropriate to participate in this clinical trial for patients with poor compliance or other unsuitable factors.
研究组 & 干预措施
68Ga-pentixafor and 18F-FDG PET/CT
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.
干预措施: 68Ga-pentixafor (Drug)
68Ga-pentixafor and 18F-FDG PET/CT
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.
干预措施: PET/CT (Device)
结局指标
主要结局
Diagnostic Accuracy of 68Ga-pentixafor PET/CT Compared to 18F-FDG PET/CT in Hematological Malignancies
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Correlation Between CXCR4 Expression and [⁶⁸Ga]Ga-pentixafor PET/CT Parameters(Two years)
- Correlation between del(17p) status and TLU on [68Ga]Ga-pentixafor PET/CT(Two years)
- Radiogenomic Model for Risk Prediction Using AI(Two years)
研究者
Yong He
Principal Investigator
Zhongnan Hospital