Neuroendocrine Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUG68Ga-DOTATATE
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.
Exclusion criteria
* pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax | through study completion, an average of 3 years | 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. |
| Diagnostic value | through study completion, an average of 3 years | Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progressive free survival(PFS) | 1 year and 5 years after been diagnosed | Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT |
| Diagnostic value in different grades/types of NET | through study completion, an average of 3 years | Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on. |
| Risk stratification | through study completion, an average of 3 years | Analysis of risk factors and OS/PFS |
| SSTR expression/Ki67 and SUV | through study completion, an average of 3 years | Correlation between SSTR expression/Ki 67 and SUV in PET |
| Overall Survival(OS) | 1 year and 5 years after been diagnosed | Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD,PhD
Outcome results
None listed