NCT07677787

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
May 2026May 2028

Study Start

First participant enrolled

May 9, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

July 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

June 8, 2026

Last Update Submit

June 25, 2026

Conditions

PET/CTSmall Cell Lung Cancer ( SCLC )DLL3-targeted PET/CTDelta-like Protein 3

Keywords

DLL3-targeted PET/CTPET/CTSmall Cell Lung CancerSCLCDelta-like protein 3

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

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

    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).

Study Arms (1)

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.

Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT

Interventions

conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CTDIAGNOSTIC_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.

DLL3-targeted PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • The inability or unwillingness of the research participant or legal representative to provide written informed consent.
  • Inability to complete PET/CT imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Liang Zhao

CONTACT

86 18818350620wzhaoliang01@163.com

Haojun Chen

CONTACT

leochen0821@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

July 1, 2026

Study Start

May 9, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

July 1, 2026

Record last verified: 2026-05

Locations

CN(1)