Comparing DLL3 PET/CT to Standard Scans in Neuroendocrine Cancer (NCT07733024) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparing DLL3 PET/CT to Standard Scans in Neuroendocrine Cancer
China200 participantsStarted 2026-07-06
Plain-language summary
This study is testing a new PET/CT scan that uses a special tracer called \[⁶⁸Ga\]Ga-DLL3 nanobody to see if it can better detect cancer spread (metastases) in people with neuroendocrine tumors than the standard scans currently used (FDG PET/CT or PSMA PET/CT). DLL3 is a protein found on the surface of many neuroendocrine tumor cells, and the new tracer is designed to stick to this protein, making tumors visible on the scan. The goal is to find out whether this new imaging method can give doctors more accurate information about where the cancer has spread and help them choose the most appropriate treatment for each patient.
The study is prospective, multi-center, and self-controlled, meaning each participant will receive both the new scan and the standard scan, allowing a direct side-by-side comparison in the same person. Depending on the type of neuroendocrine tumor, participants will be assigned to one of two groups: one group will be compared with FDG PET/CT and the other with PSMA PET/CT. The two scans will be performed within two weeks of each other, and all images will be read by independent experts who do not know the patient's clinical history, to ensure objective and unbiased results.
The investigators plan to enroll about 180-200 patients aged 18 or older who have confirmed neuroendocrine tumors with at least two metastatic sites. The total duration of participation is approximately 6 months, consisting of a screening period of up to 14 days, two imaging scans completed within 2 days, and a final follow-up visit at 6 months to evaluate participants' health and disease progression. Participation is entirely voluntary, and participants may withdraw at any time without affecting participants' standard medical care.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ×…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT in Detecting Metastatic Lesions
Timeframe: Baseline (within 14 days of enrollment) and Month 6