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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 pheochromocytoma.
Pheochromocytoma 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 pheochromocytoma will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-MFBG PET/CT in Pheochromocytoma | Each patient receive a single intravenous injection of 18F-MFBG 5.55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-MFBG | Drug | Patients with pheochromocytoma 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 |
|---|---|---|
| Correlation between positive and negative 18F-mFBG PET/CT or PET/MR Imaging and pathological diagnosis and treatment effect in patients with pheochromocytoma. | Main outcome measure | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma. | Secondary outcome measure | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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patients with suspected or confirmed pheochromocytoma
| 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 |
|---|---|
| D010673 | Pheochromocytoma |
| ID | Term |
|---|---|
| D010235 | Paraganglioma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C107924 | 3-fluorobenzylguanidine |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |