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

• Conditions: Neuroendocrine Tumors
• Interventions: Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET; Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC

• Registration Number: NCT03288597
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2017-09-16
• Study First Submitted QC: 2017-09-16
• Last Update Submitted: 2017-09-16
• Study First Posted: 2017-09-20
• Last Update Posted: 2017-09-20
• Primary Completion: 2018-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. sign written informed consent form
2. age ≥ 18 years
3. pathologically confirmed neuroendocrine, Ki67>=10%;
4. ECOG 0-1;
5. No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
6. Unresectable disease;
7. 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);
8. Predicted survival >=3 months;
9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria

1. In the process of antitumor therapy with effective response;
2. Refuse to accept PET/CT;
3. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
4. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A: advanced and metastatic neuroendocrine tumors	68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET	Advanced and metastatic neuroendocrine tumors receive syestematic treatment
A: advanced and metastatic neuroendocrine carcinomas	68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC	Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Compare SUVmax, tumor/liver ratio as a prognostic marker	3 year
The correlation between positive rate and SUV of PET/CT and prognosis	3 year

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China