A Prospective, Multi-Center, Self-Controlled Phase IIa Clinical Trial Evaluating the Diagnostic Performance and Clinical Impact of [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT Compared to [¹⁸F]FDG or [⁶⁸Ga]Ga-PSMA PET/CT in Patients With Metastatic Neuroendocrine Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT in Detecting Metastatic Lesions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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).
结局指标
主要结局
Diagnostic Accuracy of [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT in Detecting Metastatic Lesions
时间窗: Baseline (within 14 days of enrollment) and Month 6
Sensitivity and specificity of \[⁶⁸Ga\]Ga-DLL3 nanobody PET/CT for detecting metastatic lesions in patients with neuroendocrine neoplasms, using a composite reference standard (incorporating histopathology, conventional imaging \[FDG/PSMA PET/CT, diagnostic CT/MRI\], and 6-month clinical/imaging follow-up) as the truth standard.
次要结局
- Lesion Detection Rate(Baseline (within 14 days of enrollment))
- Clinical Management Change Rate(Baseline (at time of image interpretation, within 14 days of enrollment))
- Safety and Tolerability(Up to 24 hours post-injection)
- Correlation with DLL3 Expression(At study completion (expected at Month 6))
- Target-to-Background Ratio (TBR)(Baseline (within 14 days of enrollment))
研究者
Tingting Yuan
Postdoctoral Fellow; Attending Physician
Peking University First Hospital