用于检测钠-葡萄糖转运以早期诊断肺癌的研究性扫描 (Me-4FDG PET/CT)
用于肺癌早期诊断的钠-葡萄糖转运的正电子发射断层扫描检测
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.
研究概览
地位
条件
详细说明
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:
Patients receive Me-4FDG tracer intravenously (IV) and then undergo PET/CT over 15 minutes.
After completion of study , patients are followed up at 7 days.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
California
-
Los Angeles、California、美国、90095
- Yesenia Calzada
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Diagnosis of diabetes
- Current treatment with SGLT2 inhibitors or metformin
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes. |
Correlative studies Undergo PET/CT
其他名称：
Undergo PET/CT
其他名称：
Given IV
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
大体时间：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. |
within one month of surgery or biopsy
|
|
Specificity of Me-4FDG for lung cancer
大体时间：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. |
within one week of experimental PET/CT scan
|
|
Optimal combination of sensitivity and specificity
大体时间：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. |
within one week of experimental PET/CT scan
|
|
Incidence of adverse events of Me-4FDG
大体时间：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. |
From baseline to one week after Me-4FDG administration
|
|
Efficacy of Me-4FDG in diagnosing lung cancer
大体时间：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. |
within one week of the experimental PET/CT scan
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
大体时间：within one month of surgery or biopsy
|
Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade. |
within one month of surgery or biopsy
|
|
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
大体时间：within two months of surgery or biopsy
|
Will be evaluated experimentally with validated specific antibodies. |
within two months of surgery or biopsy
|
合作者和调查者
调查人员
- 首席研究员：Claudio Scafoglio, MD, PhD、UCLA / Jonsson Comprehensive Cancer Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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