CXCR4-targeted PET/CT Imaging in Hematological Malignancies

Study Overview
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Brief Summary
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The incidence and mortality of hematological malignancies remain high. Although 18F-FDG PET/CT imaging is the most common molecular imaging technique used in clinic, the non-specific uptake of 18F-FDG leads to the problems of false negative or positive in hematological malignancies, which makes it difficult to diagnose and evaluate the efficacy. CXCR4 (C-X-C Chemokine Receptor Type 4) is overexpressed in various hematological malignancies, and is associated with poor prognosis. CXCR4-targeted molecular imaging, such as 68Ga-pentixafor PET/CT imaging, has an important potential in hematological malignancies. Therefore, this study will evaluate the efficacy of CXCR4-targeted PET/CT imaging for diagnosis and staging of hematological malignancies, compared with 18F-FDG PET/CT imaging.

Official Title
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An Exploratory, Open-Label, Single Center Study of CXCR4-targeted PET/CT Imaging for Evaluation of Hematological Malignancies

Conditions
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CXCR4, PET/CT, Hematological Malignancy

Intervention / Treatment
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* Drug: 68Ga-pentixafor
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-pentixafor and 18F-FDG PET/CT<br>Investigators recruit patients with highly suspected, or newly diagnosed, or relapsed hematological malignancies. Then patients undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. | Drug: 68Ga-pentixafor<br>* All participants undergo intravenous administration of 68Ga-pentixafor (1.85-3.71 MBq/kg body weight).<br>Device: PET/CT<br>* PET/CT imaging is performed 1 h after intravenous injection of 68Ga-pentixafor.<br>* Other names: Positron Emission Tomography/Computed Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. | For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results. | Two years | 
| Specificity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. | For subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies who undergo 68Ga-pentixafor and 18F-FDG PET/CT imaging in one week. Diagnosis and staging results of 68Ga-pentixafor PET/CT will be compared to 18F-FDG PET/CT imaging, pathology and clinical follow-up results. | Two years | 
| Accuracy of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. | Taking the pathology or clinical follow-up as gold standard, the probability of accurate diagnosis and staging (including true positive and true negative) for 68Ga-pentixafor PET/CT imaging will be calculated in subjects with clinically highly suspected, or newly diagnosed, or relapsed hematological malignancies. The result will be compared to 18F-FDG PET/CT imaging. | Two years |