99mTc/68Ga Labeled Anti-PD-L1 sdAb in Assessment of Programmed Death Ligand-1 Expression in Non-small Cell Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan
研究概览
简要总结
To evaluate the safety, dosimetry and efficacy of 99mTc/68Ga labeled anti-PD-L1 single domian antibody (sdAb) (Product Code Name: 99mTc-NM-01 and 68Ga-NM-01) in the diagnostic imaging PD-L1 expression in Non-Small Cell Lung Cancer (NSCLC) and compare it with the existing gold standard "biopsy PD-L1 detection". It is also to establish a new clinical method of non-invasive PD-L1 expression detection in NSCLC using 99mTc/68Ga labeled anti-PD-L1 sdAb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
- •Male or female, aged 18-75 years old
- •Previous diagnosis of non-small cell carcinoma, confirmed with pathology tests
- •AST, ALT, BUN, Cr not more than double the normal values
- •Patients with no current history of hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases
排除标准
- •Severe infection
- •Unable to provide biopsy sample for testing PD-L1 expression level
- •Patients with pacemakers
- •Pregnant and lactating women
- •Investigators professional decision that the subject should not participate in this clinical study
结局指标
主要结局
Semiquantitative Assessment of Lung Lesions in 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET Scan
时间窗: 1 year
Patients in the 99mTc-NM-01 group will be administered 3-12 MBq/kg of 99mTc-NM-01 and patients in the 68Ga-NM-01 group will be administered 0.75-4 MBq/kg of 68Ga-NM-01. The semiquantitative analysis of the region of interest (ROI) will be performed in lung lesions. Higher level of PD-L1 expression (Tumor proportion score, TPS), higher ROI in tumor. No expression TPS \< 1%; Low expression TPS 1 - 49%; High expression TPS ≥ 50%.
Visual Assessment of PD-L1 expression in NSCLC using 99mTc-NM-01 SPECT/CT and 68Ga-NM-01 PET/CT Scan
时间窗: 1 year
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99mTc-NM-01 and 68Ga-NM-01 in lung lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
次要结局
- Adverse Drug Reaction Report(7 days)
- PD-L1 expression levels(1 year)
- New tumor lesion detection(1 year)
研究者
Zhao Jin Hua, MD
Director Department of Nuclear Medicine, Principal Investigator, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine