Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms

Study Overview
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Brief Summary
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68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.

Official Title
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A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET
* Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign written informed consent form age ≥ 18 years pathologically confirmed neuroendocrine, Ki67>=10%; ECOG 0-1; No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors; Unresectable disease; At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions); Predicted survival >=3 months; Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women; Sexually active males or females willing to practice contraception during the study until 30 days after end of study. Exclusion Criteria: In the process of antitumor therapy with effective response; Refuse to accept PET/CT; Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study; Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A: advanced and metastatic neuroendocrine tumors<br>Advanced and metastatic neuroendocrine tumors receive syestematic treatment | Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET<br>* At the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT<br>|
| A: advanced and metastatic neuroendocrine carcinomas<br>Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment | Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC<br>* At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between positive rate and SUV of PET/CT and prognosis |  | 3 year | 
| Compare SUVmax, tumor/liver ratio as a prognostic marker |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive rate, SUVmax, relationship