Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT: Participants will undergo DLL3-Targeted PET/CT imaging for the evaluation of tumor lesions. Imaging findings will be compared with conventional imaging modalities as part of the study analysis.
Study summary
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed neuroendocrine carcinoma, and to compare with conventional imaging modalities.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Adult patients (aged 18 years or older);
* Patients with suspected, newly diagnosed, and previously treated neuroendocrine carcinoma(supporting evidence may include imaging findings and pathology report);
* Serum ProGRP or NSE level ≥ 3 times the upper limit of normal;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
* Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Exclusion Criteria:
* The inability or unwillingness of the research participant or legal representative to provide written informed consent.
* Inability to complete PET/CT imaging.
Primary outcome measure(s)
Changes in vital signs after administration of the DLL3-targeted tracer — 1 day Vital signs will be monitored before and after administration of the DLL3-targeted tracer, including body temperature, pulse rate, respiratory rate, and blood pressure. Units of Measure: Body temperature (°C); Pulse rate (beats/min); Respiratory rate (breaths/min); Blood pressure (mmHg).
Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body — 1 year Radiation dosimetry will be calculated using serial whole-body PET/CT imaging after administration of the DLL3-targeted tracer. Time-activity curves will be generated for major organs, and absorbed doses will be estimated using standard internal dosimetry software (e.g., OLINDA/EXM). Unit of Measure: Absorbed radiation dose (mGy/MBq).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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