DLL3-Targeted PET/CT in Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18 years or older);
Patients with suspected, newly diagnosed, and previously treated small cell lung cancer(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.
Disqualifiers
The inability or unwillingness of the research participant or legal representative to provide written informed consent.
Inability to complete PET/CT imaging.
Trial design
Design model
Single group
Treatments tested in this trial
conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT
Diagnostic testParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: DLL3-targeted PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer
Vital signs, including body temperature, pulse rate, respiratory rate, systolic blood pressure, and diastolic blood pressure, will be monitored before and after administration of the DLL3-targeted tracer. Participants with at least one clinically significant abnormality in vital signs after tracer administration, as determined by the investigator, will be reported. Unit of Measure: Participants
Time frame
1 day2
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 yearSecondary outcomes
1
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
Baseline2
Lesion detection rate of 68Ga-DLL3 PET/CT
Time frame
The number and proportion of primary and metastatic lesions detected by 68Ga-DLL3 PET/CT compared with conventional imaging modalities (CT, MRI, bone scintigraphy, or 18F-FDG PET/CT, as applicable).Sponsors and contacts
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Source ClinicalTrials.gov