DLL3-Targeted PET/CT in Small Cell Lung Cancer

Official title

Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Small Cell Lung Cancer

Overview

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 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.

Primary outcome measures

• Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer [Time frame: 1 day]
• Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body [Time frame: 1 year]

Secondary outcome measures (2)

• Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax) [Time frame: Baseline]
• 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT07677787 · XMYY-2026KY105

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗