Small Cell Lung Cancer
Conditions
Interventions
Index test:DLL3-Targeted Imaging Agent (DLL3I)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged 18 years and older), of any gender. 2. For cases of newly diagnosed small cell lung cancer (SCLC), this study plans to initially recruit 10 treatment-naïve patients with a clinical suspicion of SCLC for research and analysis; patients must agree to undergo surgical treatment or tissue biopsy. 3. Patients capable of providing informed consent (if the patient possesses the capacity to provide informed consent, they must sign the informed consent form personally; if the patient lacks this capacity, the form must be signed by a family member or legal representative) and who agree to participate in accordance with the guidelines of the Institutional Review Board (IRB). 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score between 0 and 2; and the subject must present with at least one pulmonary lesion with a maximum diameter greater than 1 cm (measured via CT according to RECIST version 1.1 criteria). 5. Complete Blood Count (CBC): White Blood Cell (WBC) count between 4 and 10 × 10^9/L; Platelet (PLT) count between 100 and 300 × 10^9/L; Hemoglobin (Hb) level between 120 and 160 g/L. 6. Renal Function: Serum creatinine level at or below the upper limit of the normal range. 7. Hepatic Function: Bilirubin, AST (SGOT), and ALT (SGPT) levels at or below the upper limit of the normal range. 8. Electrocardiogram (ECG): No significant abnormalities. 9. Patients of childbearing potential must agree to use appropriate contraception.
Exclusion criteria
Exclusion criteria: 1. Subjects with contraindications to PET/CT scanning or who are unable to cooperate with the examination. This includes, but is not limited to: pregnancy or lactation; inability to establish venous access or intolerance to intravenous injection; known or suspected allergy to the investigational drug or its components (including a history of severe allergy or anaphylaxis); severe claustrophobia, etc. 2. Within the past year, subjects who have participated in other research protocols or clinical care—excluding the anticipated radiation exposure associated with participation in this clinical study—resulting in an effective radiation dose exceeding 50 mSv. 3. Subjects with any of the following difficult-to-control clinical conditions: including, but not limited to, systemic diseases such as coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, hepatic failure, acute stroke, acute myocardial infarction, or unstable diabetes. Subjects with a history of head injury or intracranial surgery; hypoxia, sepsis, or severe infectious diseases; psychiatric disorders, epilepsy, or severe depression (or a history thereof); or a history of positive testing for Human Immunodeficiency Virus (HIV). 4. Subjects with significant abnormalities in laboratory parameters—including, but not limited to, hemoglobin (Hb), white blood cell count (WBC), C-reactive protein (CRP), platelet count (PLT), or drug allergies—that are considered by the clinician to be clinically significant or indicative of an unstable condition. 5. History of substance abuse or alcoholism within the past 3 months. 6. Subjects with any clinical condition that the Principal Investigator deems likely to be caused or potentially exacerbated by the investigational product. 7. Potential allergy to any component of the DLL3I injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized Uptake Value;Tumor-to-Background Ratio; | — |
Countries
China
Contacts
Public ContactGuan Yihui
Huashan Hospital, Fudan University
Outcome results
None listed