Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study
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
- Correlation between metabolic imaging parameters and treatment response
研究概览
简要总结
- Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis.
- Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs.
- Study subject: patients with non-small cell lung cancer who will be treated with ICIs.
- Study design: prospective observational study
- Intervention: F-18 FDG PET/CT
详细描述
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Study purposes
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Primary purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and treatment response in non-small cell lung cancer (NSCLC) patients treated with ICIs.
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Secondary purpose: To evaluate the association between PET imaging parameters, patient prognosis, CT imaging parameters, and other biomarkers, and to compare treatment response evaluation criteria.
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Background: development of ICIs opened a new paradigm for cancer treatment. It enables long-term survival of patients with advanced cancers, which could not be expected to be effective with conventional chemotherapy. Therapeutic response and prognosis to ICIs have unique characteristics which are different from those of conventional cytotoxic or targeted therapies. Even if the initial response rate is not high, if the treatment effect is effective, the effect is long-lasting and enabling long-term survival. With the evaluation criteria based on the change in tumor size, it is difficult to differentiate between an atypical response of ICIs and disease progression. Therefore, a new type of approach is required. F-18 FDG PET/CT is an imaging method that is currently used for many cancers. In recent studies on the response evaluation of ICIs using FDG PET/CT, FDG PET/CT has shown potential as a predictive tool of therapeutic response and prognosis. However, despite the potential, most of the related studies are retrospective design and small in scale. Additionally, it is not known which PET imaging features are suitable for predicting treatment response and prognosis. A novel image analysis method based on image informatics has been tried. After extracting image features from imaging modalities such as PET, CT, MRI, they are fused with clinical information and genetic information and analyzed through an artificial intelligence-based platform. It has been reported that a predictive model based on CT image features can predict the treatment response to ICI. However, the efficacy of imaging biomarkers for predicting ICI treatment response has not yet been proven, and further prospective studies are needed. Therefore, patients with NSCLC to be treated with ICI will receive FDG PET/CT before and during treatment in this study. In addition, PET images will be comprehensively analyzed together with other image data, biomarkers, and clinical data, and will be used as basic data for future ICI prediction models.
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Study design: single institution, single-arm, prospective observational study
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Study population: NSCLC patients who are scheduled to receive ICI in our institution
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years old or over
- •pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma
- •patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab)
- •ECOG performance status ≤ 2
- •A person who have heard the detailed explanation of this clinical trial and are willing to voluntarily decide to participate and sign the informed consent form
排除标准
- •subjects without measurable lesion: They must have at least one measurable lesion with a diameter of 10 mm by spiral CT or multi-detector CT (MD CT) or 20 mm or larger by conventional CT.
- •subjects with a history of other malignant diseases within the past 5 years, except for treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, cured thyroid cancer, and early gastric cancer
- •subjects with clinically significant uncontrolled seizures, central nervous system disease, or psychiatric disorders that, in the investigator's judgment, interferes with or is likely to interfere with the understanding of informed consent
- •subjects with uncontrolled diabetes
- •subjects with severe uncontrolled infection
- •subjects who underwent major surgery within 4 weeks prior to the start of the clinical trial or who have not fully recovered from the effects of major surgery
- •pregnant or lactating patients
- •subjects who have not received a pregnancy test or have a positive result during the basic test (menopause women with amenorrhea period of at least 12 months or longer are considered infertile subjects)
- •women or men of childbearing potential who are unwilling to use contraception during the clinical trial period
结局指标
主要结局
Correlation between metabolic imaging parameters and treatment response
时间窗: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.
* Analyze the correlation between metabolic imaging indicators (SUVmax, SULpeak, MTV, TLG, SLR of tumor lesions on 1st scan, % change of SUVmax, % change of SULpeak, % change of MTV, % change of TLG, % change of SLR between 1st and 2nd scans) and treatment response. * Treatment response: If the patient maintains a stable disease state or above based on the CT response evaluation criteria for more than 6 months, it is considered to have a response. * % change = \[((Value of SCAN2 - value of SCAN1)/value of SCAN1) X 100\] * Analysis model: point-biserial correlation analysis (Two-tailed test)
次要结局
- Correlation between biomarkers and patient prognosis(The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.)
- Correlation between metabolic imaging parameters and patient prognosis(The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.)
- Correlation between metabolic imaging parameters and CT imaging parameters obtained from contrast-enhanced CT(Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.)
- Correlation between imaging markers and non-imaging biomarkers(Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.)
- Correlation between biomarkers and treatment response(The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.)
- Comparison of clinical outcome according to FDG PET/CT evaluation criteria (PERCIST vs. iPERCIST)(The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.)
- Comparison of FDG PET/CT evaluation criteria with CT evaluation criteria (iRECIST and imRECIST)(Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.)
研究者
Ho Yun Lee
Associate professor
Samsung Medical Center