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NCT Number: NCT07677787

DLL3-Targeted PET/CT in Small Cell Lung Cancer

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

Liang Zhao

CONTACT

[email protected]

86 18818350620

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer

    Time frame: 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

  2. Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body

    Time frame: 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 outcomes

  1. Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)

    Time frame: 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Haojun Chen

CONTACT

[email protected]

Liang Zhao

CONTACT

[email protected]

86 18818350620

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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