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

NCT ID: NCT03288597

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-09-01

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.

Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A: advanced and metastatic neuroendocrine tumors

Advanced and metastatic neuroendocrine tumors receive syestematic treatment

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

Intervention Type RADIATION

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

A: advanced and metastatic neuroendocrine carcinomas

Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment

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

Intervention Type RADIATION

At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT

Interventions

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

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

Intervention Type RADIATION

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

At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT

Intervention Type RADIATION

Eligibility Criteria

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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；
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Shen Lin

MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin Shen, Professor

Role: CONTACT

[email protected]
01088196561

Facility Contacts

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Shen Lin, Professor

Role: primary

[email protected]
010-88196561

Other Identifiers

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68Ga&FDG PET/CT

Identifier Type: -

Identifier Source: org_study_id