An interventional study of Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT in DLL3-expressing Tumors, PET / CT and Neuroendocrine Cancer, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Diagnostic
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.
This study is designed to investigate DLL3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or confirmed neuroendocrine carcinoma.
In this research, patients with neuroendocrine carcinoma or highly suspected recurrence detection underwent contemporaneous DLL3-targeted PET/CT and conventional imaging (such as CT, MRI or 18F-FDG) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standardized uptake value (SUVmax). By correlating immunohistochemistry with tumor uptake of the DLL3-targeted tracer, the investigators will explore the feasibility of visualizing tumor DLL3 expression using DLL3-targeted PET. The numbers of positive tumor lesions of conventional imaging and DLL3-targeted PET/CT were recorded by visual interpretation. The diagnostic accuracy of DLL3-targeted was calculated and compared to conventional imaging. Intertumoral heterogeneity was assessed using the coefficient of variation (CV) of SUVmax across all lesions within each patient.
236 studies on the registry are indexed under Carcinoma, Neuroendocrine; 66 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 184 interventional studies indexed under Carcinoma, Neuroendocrine.
Browse Carcinoma, Neuroendocrine studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each subject receives a single intravenous injection of DLL3-targeted probe and undergoes PET/CT imaging within the specified time.
Diagnostic Test: 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.
Changes in vital signs after administration of the DLL3-targeted tracer
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).
Time frame: 1 day
Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body
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).
Time frame: 1 year
Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)
Tumor DLL3 expression will be quantified using immunohistochemistry (IHC) and reported as an H-score (range 0-300). Tumor uptake of the DLL3-targeted PET tracer will be measured as maximum standardized uptake value (SUVmax) on PET/CT imaging. The correlation between DLL3 IHC H-score and PET SUVmax will be analyzed to evaluate the feasibility of noninvasively visualizing and quantifying tumor DLL3 expression using DLL3-targeted PET imaging.
Time frame: 1 year
Intertumoral heterogeneity
Intertumoral heterogeneity of DLL3 was assessed using the coefficient of variation (CV) of SUVmax across all lesions within each patient.
Time frame: 1 year
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital of Xiamen University