Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radiation dosimetry of whole-body
研究概览
简要总结
This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.
详细描述
A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 and EpCAM expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.
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 18-80 years;
- •Imaging studies suspecting non-small cell lung cancer;
- •Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;
- •Patients or family members agreed to participate in this clinical study and signed an informed consent form.
排除标准
- •Women during pregnancy and lactation;
- •Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;
- •Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;
- •Patient is unable to cooperate in completing the PET/CT examination;
- •Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical study;
- •Patient should not participate in this clinical trial in the opinion of the investigator.
研究组 & 干预措施
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-T4 (Drug)
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-RT4 (Drug)
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-T4 (Drug)
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-RT4 (Drug)
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [18F]F-RESCA-EPCD6 (Drug)
ImmunoPET imaging in patients with lung cancers
Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning.
干预措施: [68Ga]Ga-NOTA-EPCD6 (Drug)
结局指标
主要结局
Radiation dosimetry of whole-body
时间窗: 1 day from injection of the tracers
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
时间窗: 1 day from injection of the tracers
Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
SUV of tumors
时间窗: 1 day from injection of the tracers
The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Radiation dosimetry of tissues/organs
时间窗: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of tumors
时间窗: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Diagnostic sensitivity
时间窗: 30 days
Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Diagnostic specificity
时间窗: 30 days
Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Accuracy
时间窗: 30 days
Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Positive Predictive Value (PPV)
时间窗: 30 days
PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Negative Predictive Value (NPV)
时间窗: 30 days
NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
次要结局
- ImmunoPET/CT in altering initial staging for patients with lung tumors(3-6 months)
- ImmunoPET/CT for postoperative surveillance for patients with lung tumors(3-6 months)
- ImmunoPET/CT for restaging for patients with lung tumors(3-6 months)
- ImmunoPET/CT in evaluating treatment responses(1-2years)
- ImmunoPET/CT in identifying inflammation and tumors in the lungs(1 day from injection of the tracers)