Delta-like Protein 3, DLL3-targeted PET/CT, PET/CT, Small Cell Lung Cancer ( SCLC )
Conditions
Keywords
DLL3-targeted PET/CT, PET/CT, Small Cell Lung Cancer, SCLC, Delta-like protein 3
Brief summary
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.
Detailed description
This study is designed to investigate DLL3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or confirmed small cell lung cancer (SCLC).In this research, patients with SCLC 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.
Interventions
DIAGNOSTIC_TESTconventional 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.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer | 1 day | 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 |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax) | Baseline | 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. |
| Lesion detection rate of 68Ga-DLL3 PET/CT | 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). | — |
Countries
China
Contacts
CONTACTLiang Zhao
CONTACTHaojun Chen
Outcome results
None listed