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The aim of this study is to evaluate the efficacy of 18F-Pentixafor PET imaging in the diagnosis, staging and response evaluation of hematological malignancies.
18F-FDG PET imaging based on the principle of glucose metabolism imaging is currently dominant in the staging and efficacy evaluation of lymphoma, but it is not suitable for a wider range of hematological tumors. Chemokine receptor 4 (CXCR-4) is a G protein-coupled receptor, which is overexpressed in a variety of hematological malignancies (MM, leukemia, lymphoma, etc.). It promotes tumor growth, invasion, metastasis, drug resistance, immune escape, and is associated with poor prognosis of tumors. 18Fluorine18 (18F)-NOTA-Pentixafor (18f-pentixafor) is a novel specific molecular probe targeting CXCR-4. Compared with 68Ga-Pentixafor, 18f-pentixafor has a longer half-life. More patients can be used in one synthesis, and the image quality is better and the spatial resolution is higher. Patients can undergo PET at 1 h after injection without special preparation. The aim of this study is to evaluate the performance of 18F-Pentixafor PET imaging in the diagnosis, staging, and response evaluation of hematological malignancies. Patients with suspected or histologically confirmed hematological malignancies will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Pentixafor PET/CT in Hematologic Malignancies | Each patient receive a single intravenous injection of 18F-Pentixafor 55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Pentixafor | Drug | Patients with hematological malignancies receive 55 MBq/kg of 18F-Pentixafor intravenously followed by PET/CT or PET/MR after 60min of injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | Sensitivity, specificity, positive and negative predictive value of 18F-Pentixafor PET/CT and PET/MR Imaging in hematological malignancies. | through study completion, an average of 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-Pentixafor PET performence compared with 18F-FDG | Differences in sensitivity and specificity: McNemar test Differences in AUC values: DeLong test Detection rate of lesions: chi-square test. SUVmax/TBR difference: Paired t-test (normal distribution) or Wilcoxon signed-rank test (non-normal) Correlation analysis: Spearman's rank correlation was used to assess the correlation of uptake between the two imaging methods. Subgroup analysis: Chi-square test or Logistic regression was used to analyze heterogeneity in diagnostic power stratified by disease type and stage. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with suspected or confirmed Hematologic Malignancies
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peipei Wang, MD | Contact | 86 18511395988 | wpp199411@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| up to 24 months |
| Deauville Score |
| through study completion, 3-4 years |