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

Peking University

Status: Unknown

Conditions: Neuroendocrine Tumors

Treatments: Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET; Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC

Study type: Observational

Funder types: Other

Identifiers

NCT03288597

68Ga&FDG PET/CT

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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；

Trial design

146 participants in 2 patient groups

A: advanced and metastatic neuroendocrine tumors

Description:

Advanced and metastatic neuroendocrine tumors receive syestematic treatment

Treatment:

Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET

A: advanced and metastatic neuroendocrine carcinomas

Description:

Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment

Treatment:

Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC