New DLL3 PET/CT imaging for neuroendocrine tumors compared with standard scans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial tests a novel PET/CT imaging tracer, 68Ga-DLL3, designed to bind DLL3 on neuroendocrine tumor cells. Participants receive both the new DLL3 PET/CT and a standard scan (FDG PET/CT or PSMA PET/CT) in a direct, side-by-side comparison. The study is prospective and multi-center, with patients grouped by tumor type to compare the two reference scans. The aim is to determine if DLL3-targeted imaging provides more accurate information on metastases to guide treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years at the time of signing the informed consent form, male or female.
* Histologically or cytologically confirmed neuroendocrine neoplasms (NENs), including but not limited to small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), gastroenteropancreatic neuroendocrine tumors (GEP-NENs), or other NEN subtypes.
* Patients with strong clinical and radiological suspicion of NENs based on imaging (CT/MRI/conventional PET/CT) and clinical presentation.
* At least 2 evaluable metastatic lesions (multiple metastases) confirmed by conventional imaging (CT/MRI/PET/CT).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy \> 3 months.
* Voluntarily agrees to participate and provides written informed consent.
* Females of childbearing potential and male participants agree to use reliable contraceptive methods for 6 months after the last study drug administration.
* Willing and able to comply with scheduled visits, diagnostic procedures, clinical laboratory tests, and other study procedures.

Exclusion Criteria:

* Known severe immediate-type hypersensitivity or anaphylactic reaction to DLL3-targeted tracers, nanobody proteins, chelators, buffer components, or excipients.
* Pregnant or breastfeeding women.
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m².
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN).
* Total bilirubin \> 1.5 × ULN.
* Inability to tolerate or cooperate with PET/CT imaging procedures, including but not limited to: severe claustrophobia, inability to remain supine and still for at least 30 minutes, or inability to establish adequate intravenous access.
* Received chemotherapy, biological therapy, endocrine therapy, molecular targeted therapy, or investigational drug therapy within 4 weeks prior to enrollment.
* Currently participating in another interventional clinical trial.
* Prior exposure to any DLL3-targeted therapeutic agent (e.g., Tarlatamab, bispecific T-cell engagers, or DLL3-targeted radioimmunotherapy) or DLL3-targeted radiotracer.
* Prior radionuclide therapy or diagnostic scan with an interval of less than 10 physical half-lives of the administered radionuclide prior to study tracer administration.
* History of any other malignancy within 5 years prior to screening, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies with negligible risk of recurrence in the investigator's opinion.
* Clinically significant abnormalities on physical examination, electrocardiogram (ECG), or clinical laboratory tests during screening that, in the investigator's opinion, may compromise safety or study compliance.
* Any other condition that, in the investigator's opinion, makes the patient unsuitable for study participation (e.g., severe psychiatric disorders, substance abuse, poor compliance).

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Department of Nuclear Medicine, Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Tingting Yuan, MD
• Email: biluohtt@163.com
• Phone: +86 13051707479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.