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Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.
Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Experimental | Inject 68Ga-DOTATATE and then perform PET/CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE | Drug | Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SUVmax | SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive. | through study completion, an average of 3 years |
| Diagnostic value | Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value in different grades/types of NET | Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on. | through study completion, an average of 3 years |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, MD,PhD | Contact | +86-10-69154196 | zhuzhh@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu, MD,PhD | Peking Union Medical College Hopital, Chinese Academy of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34146130 | Derived | Liu Q, Zang J, Yang Y, Ling Q, Wu H, Wang P, Lu L, Zhu Z. Head-to-head comparison of 68Ga-DOTATATE PET/CT and 18F-FDG PET/CT in localizing tumors with ectopic adrenocorticotropic hormone secretion: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4386-4395. doi: 10.1007/s00259-021-05370-8. Epub 2021 Jun 19. |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
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Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
| 1 year and 5 years after been diagnosed |
| Progressive free survival(PFS) | Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT | 1 year and 5 years after been diagnosed |
| SSTR expression/Ki67 and SUV | Correlation between SSTR expression/Ki 67 and SUV in PET | through study completion, an average of 3 years |
| Risk stratification | Analysis of risk factors and OS/PFS | through study completion, an average of 3 years |
| D009380 | Neoplasms, Nerve Tissue |