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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03288597
Enrollment
146
Registered
2017-09-20
Start date
2017-09-01
Completion date
2020-09-01
Last updated
2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

positive rate, SUVmax, relationship

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.

Interventions

RADIATION68Ga-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

RADIATION68Ga-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

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response3 years

Secondary

MeasureTime frame
The correlation between positive rate and SUV of PET/CT and prognosis3 year
Compare SUVmax, tumor/liver ratio as a prognostic marker3 year

Countries

China

Contacts

Primary ContactLin Shen, Professor
linshenpku@163.com01088196561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026