An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, in Patients With Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Diagnostic Efficacy of 68Ga-SFB6-ZN01 PET/CT in Malignant Solid Tumors
研究概览
简要总结
This study is being done to test a new imaging agent called 68Ga-SFB6-ZN01, which helps visualize tumors using PET/CT scans. The agent attaches to a protein called integrin αvβ6, which is found on the surface of many cancer cells but rarely on normal cells. A total of 98 adults who either have a confirmed cancer diagnosis, are strongly suspected of having cancer, or may have recurrent cancer after previous treatment will be enrolled. Each participant will receive a single injection of 68Ga-SFB6-ZN01 and undergo one PET/CT scan within one week of joining the study. The main goals are: to see how safe the imaging agent is and whether it causes any side effects; to understand how the agent distributes in the body, and how much radiation exposure it gives; to determine how accurately 68Ga-SFB6-ZN01 PET/CT can detect cancerous lesions and correctly stage the disease, using biopsy results or long-term follow-up (≥6 months) as the reference standard; to explore whether the PET signal intensity (e.g., SUVmax) correlates with the expression of integrin αvβ6 in the tumor tissue. No therapeutic treatment is given in this study. Participation involves one imaging visit and follow-up contact. The results will help determine whether this new tracer should be developed further for cancer imaging.
详细描述
Study Title An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, in Patients with Malignant Tumors Background and Rationale Integrin αvβ6 is an epithelial-restricted cell surface receptor that is markedly upregulated in various carcinomas (e.g., pancreatic, lung, colorectal, head and neck, breast) during tumorigenesis and metastasis, but is minimally expressed in healthy adult tissues. This expression pattern makes αvβ6 an attractive target for molecular imaging. 68Ga-SFB6-ZN01 is a novel PET radiotracer with high affinity and selectivity for integrin αvβ6. Preclinical studies have demonstrated favorable pharmacokinetics, specific tumor uptake, and acceptable dosimetry. This first-in-human diagnostic study is designed to comprehensively evaluate the clinical performance of 68Ga-SFB6-ZN01 PET/CT.
Study Design This is an open-label, single-center, single-arm, non-randomized, interventional diagnostic study. All enrolled subjects will receive a single intravenous bolus injection of 68Ga-SFB6-ZN01 followed by whole-body PET/CT acquisition. The study is prospective and will be conducted at Zhongnan Hospital of Wuhan University.
Primary Objective and Outcome Measure The primary objective is to determine the diagnostic efficacy of 68Ga-SFB6-ZN01 PET/CT for detecting malignant lesions (primary and metastatic) in patients with proven or suspected solid malignancies. The primary outcome measure is sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) on a per-patient and per-lesion basis, using histopathology as the gold standard and/or clinical/imaging follow-up of at least 6 months. This outcome will be assessed up to 6 months post-imaging.
Secondary Objectives and Outcome Measures To assess the safety and tolerability of a single microdose of 68Ga-SFB6-ZN01. The corresponding outcome measure is the incidence, severity, and relationship of adverse events, recorded from injection to 72 hours post-injection.
To characterize the biodistribution and estimate radiation dosimetry of 68Ga-SFB6-ZN01. The outcome measures include organ-specific standardized uptake values (SUV), time-activity curves, and effective dose (mSv) calculated from serial whole-body PET/CT scans obtained in a subset of patients over 0-3 hours post-injection.
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
盲法说明
Images will be independently interpreted by at least two experienced nuclear medicine physicians who are blinded to all clinical information, including histopathological diagnosis, prior imaging findings, and patient history. Discrepancies will be resolved by consensus or a third blinded reader.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent.
- •Age ≥ 18 years, male or female.
- •Clinically suspected or pathologically confirmed malignant solid tumor, or suspicion of recurrence after treatment.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-
- •Life expectancy ≥ 6 months.
- •Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception from consent until 6 months after study agent administration.
排除标准
- •Administration of any radionuclide within a period less than 10 physical half-lives before study agent injection.
- •Concurrent participation in another interventional clinical trial involving an investigational drug or device.
- •Known hypersensitivity to 68Ga-SFB6-ZN01 or any of its excipients.
- •Inability to lie flat or remain still during PET/CT acquisition, or any contraindication to PET/CT.
- •Pregnancy or breastfeeding.
- •Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation.
研究组 & 干预措施
68Ga-SFB6-ZN01 PET/CT
Participants receive a single intravenous injection of 68Ga-SFB6-ZN01 followed by whole-body PET/CT acquisition approximately 60 minutes post-injection.
干预措施: 68Ga-SFB6-ZN01 (Drug)
结局指标
主要结局
Diagnostic Efficacy of 68Ga-SFB6-ZN01 PET/CT in Malignant Solid Tumors
时间窗: Up to 6 months post-imaging
Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of 68Ga-SFB6-ZN01 PET/CT for detecting malignant lesions (primary and metastatic), using histopathology as the reference standard and/or clinical/imaging follow-up of at least 6 months as the composite reference standard.
次要结局
- Safety and Tolerability: Incidence of Adverse Events(From injection to 72 hours post-injection)
- Safety and Tolerability: Relationship of Adverse Events(From injection to 72 hours post-injection)
- Safety and Tolerability: Severity of Adverse Events(From injection to 72 hours post-injection)
- Biodistribution: Organ-Specific Standardized Uptake Values (SUV)(At approximately 10, 60, 120, and 180 minutes post-injection)
- Biodistribution: Time-Activity Curves(From 0 to 3 hours post-injection (serial scans at 10, 60, 120, and 180 minutes))
- Staging Accuracy: Concordance with Histopathology(Baseline (at time of imaging, compared with pathology results obtained within 6 weeks))
- Radiation Dosimetry: Effective Dose(From 0 to 3 hours post-injection (serial scans at 10, 60, 120, and 180 minutes))
- Staging Accuracy: Proportion with Stage Change(Baseline)