Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Specificity of Me-4FDG for lung cancer
研究概览
简要总结
The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.
详细描述
PRIMARY OBJECTIVE:
I. Assess the safety and efficacy of alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) for early diagnosis of lung cancer.
SECONDARY OBJECTIVE:
I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(SGLT2).
OUTLINE:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Lung nodule >= 1 cm visualized by CT imaging
- •CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy
- •BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3
排除标准
- •Pregnancy
- •Diagnosis of diabetes
- •Current treatment with SGLT2 inhibitors or metformin
研究组 & 干预措施
Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
干预措施: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Drug)
Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Specificity of Me-4FDG for lung cancer
时间窗: within one week of experimental PET/CT scan
Will be estimated by the percentage of Me-4FDG negativity in lung nodules that have been determined radiologically and/or clinically to be benign with a lung-RAD (Lung Imaging Reporting and Data System), score 1-3.
Incidence of adverse events of Me-4FDG
时间窗: From baseline to one week after Me-4FDG administration
Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects.
Efficacy of Me-4FDG in diagnosing lung cancer
时间窗: within one week of the experimental PET/CT scan
Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer.
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
时间窗: within one month of surgery or biopsy
Will be determined by calculating the standardized uptake value (SUV) in the lesions and the contrast to noise ratio (CNR) relative to an area of normal lung surrounding the lesion, and evaluated by assessing the percentage of patients with a pathologic diagnosis of lung cancer that results positive at Me-4FDG PET scans.
Optimal combination of sensitivity and specificity
时间窗: within one week of experimental PET/CT scan
Will combine SUV and CNR cut-points that yield the optimal combination of sensitivity (positivity within the adenocarcinoma group) and specificity (negativity with the benign group). Optimality will be based on the cut-points that maximize the Youden index (sum of the sensitivity plus specificity). Based on the combined cut point, will construct 95% confidence intervals for the sensitivity and specificity.
次要结局
- Correlation of Me-4FDG positivity with histopathological features (tumor grade)(within one month of surgery or biopsy)
- Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)(within two months of surgery or biopsy)