DLL3-targeted PET/CT for detecting neuroendocrine carcinoma
Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Neuroendocrine Carcinoma
We are testing a DLL3-targeted PET/CT scan to see if it better finds tumors in adults with suspected or confirmed neuroendocrine carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT07458906 on ClinicalTrials.gov |
What this trial studies
Participants undergo contemporaneous DLL3-targeted PET/CT and conventional imaging (CT, MRI, or 18F-FDG PET/CT) for initial staging or suspected recurrence. Tumor uptake on the DLL3 tracer will be quantified by SUVmax and lesion detection will be compared by visual reads against standard imaging. Tumor samples will be correlated by immunohistochemistry to determine whether tracer uptake reflects DLL3 expression, and intertumoral heterogeneity will be assessed using the coefficient of variation of SUVmax across lesions. The diagnostic accuracy of DLL3-targeted PET/CT will be calculated and compared to conventional imaging.
Who should consider this trial
Good fit: Adults (18+) with suspected, newly diagnosed, or previously treated neuroendocrine carcinoma, with supportive imaging/pathology and elevated ProGRP or NSE (≥3× upper limit), able to consent and expected to live more than three months are ideal candidates.
Not a fit: Patients who cannot complete PET/CT, who have non-DLL3-expressing tumors, or who have very limited life expectancy or contraindications to PET/CT are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, DLL3-targeted PET/CT could more accurately locate DLL3-expressing neuroendocrine cancer lesions and help guide treatment decisions.
How similar studies have performed: DLL3-targeted imaging is a relatively new approach with limited published clinical data, although DLL3 has been explored as a therapeutic and diagnostic target in related neuroendocrine and small cell cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (aged 18 years or older); * Patients with suspected, newly diagnosed, and previously treated neuroendocrine carcinoma(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.
Where this trial is running
Xiamen, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Liang Zhao
- Email: wzhaoliang01@163.com
- Phone: 86 18818350620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.