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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03288597
• Other study ID #: 68Ga&FDG PET/CT
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2017
• Last updated: September 16, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2017
• Source: Peking University
• Contact: Lin Shen, Professor
• Phone: 01088196561
• Email: linshenpku[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neoplasms
• Neuroendocrine Tumors

Intervention

Radiation:
• 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
• 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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response		3 years
Secondary	The correlation between positive rate and SUV of PET/CT and prognosis		3 year
Secondary	Compare SUVmax, tumor/liver ratio as a prognostic marker		3 year