CXCR4-targeted PET/CT Imaging in Hematological Malignancies
- Conditions
- CXCR4PET/CTHematological Malignancy
- Interventions
- Device: PET/CT
- Registration Number
- NCT05255926
- Lead Sponsor
- Zhongnan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-pentixafor and 18F-FDG PET/CT 68Ga-pentixafor 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. 68Ga-pentixafor and 18F-FDG PET/CT PET/CT 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.
- Primary Outcome Measures
Name Time Method Sensitivity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. Two years 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.
Specificity of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. Two years 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.
Accuracy of 68Ga-pentixafor PET/CT for diagnosis and staging in hematological malignancies. Two years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China