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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLL3-targeted PET/CT | Experimental | Each subject receives a single intravenous injection of DLL3-targeted probe and undergoes PET/CT imaging within the specified time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Zhao | Contact | 86 18818350620 | wzhaoliang01@163.com | |
| Haojun Chen | Contact | leochen0821@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Baseline |
| 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). |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |