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The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma.
Neuroblastoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed neuroblastoma will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-MFBG PET/CT in Neuroblastoma | Each patient receive a single intravenous injection of 18F-MFBG 2-5 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-MFBG | Drug | Patients with neuroblastoma malignancies receive 5.55 MBq/kg of 18F-MFBG 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-mFBG PET/CT and PET/MR Imaging in neuroblastoma | through study completion, an average of 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-mFBG PET performence compared with other images | 18F-mFBG PET performence compared with 18F-FDG PET or MRI, McNemar test, Two-tailed,P<.05 | up to 24 months |
| Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients |
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Inclusion Criteria:
Exclusion Criteria:
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patients with suspected or confirmed neuroblastoma
| 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 |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C107924 | 3-fluorobenzylguanidine |
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This measure evaluates the association between baseline 18F-mFBG PET parameters (e.g., SUVmax, SUVmean, metabolic tumor volume [MTV], total lesion glycolysis [TLG]) and progression-free survival (PFS) in high-risk neuroblastoma patients. PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model. |
| through study completion, 3-4 years |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |