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临床试验/NCT00603057
NCT00603057已完成不适用

Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer

University of Michigan Rogel Cancer Center1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
The primary aim of this study is to investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood tests during the course of radiation therapy.

研究概览

简要总结

Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), before treatment and then again during treatment to see if it helps predict how well the treatment works for your cancer and how well your lung functions during treatment. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located.

The researchers are also doing blood tests in this study to look for markers in your blood and to see if it helps them in determining your risk of developing side effects from radiation to the lungs. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.

详细描述

Lung cancer is the leading cause of cancer deaths in the United States, of which 80% are lung cancer (NSCLC, including squamous cell lung cancer, and small cell lung cancer). Although surgery provides the best chance of cure, the majority of lung cancer require radiation for treatment. The current radiation recommendation, using modern techniques and a uniform radiation dose, generates an overall cure rate of less than 10-15%, and moderate toxicity in 10-30% of treated patients. Who can be cured and who will develop side effects? Computed tomography (CT) provides a useful tool to monitor, but a limited power to predict both tumor control and lung toxicity. Using [18F] fluorodeoxyglucose positron emission tomography (FDG-PET) and ventilation/perfusion single photon emission computed tomography (V/Q SPECT), we have recently shown changes in tumor activity and regional lung function during the course of radiation, which may be associated with long-term outcome. The general strategy of this project is to perform functional image and blood test during the course of radiation and correlate them with long-term outcomes. By completing this study, we expect to generate predictive models better than CT-based ones for both tumor control and lung toxicity.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Histologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) clinically diagnosed providing that FDG-PET is positive.
  • Stage I to III lung cancer requiring definitive irradiation with or without chemotherapy.
  • Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria.
  • Patients must be 18 years of age or older.
  • Female patients with reproductive capability must be willing to use effective contraception
  • Patients must sign an informed consent form for study.

排除标准

  • Malignant pleural or pericardial effusion.
  • Pregnancy
  • Lactation
  • Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)
  • Inability to lie flat for the duration of PET/CT and V/Q SPECT (approximately 45 minutes for each study)
  • Prisoners are excluded from this study.

结局指标

主要结局

The primary aim of this study is to investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood tests during the course of radiation therapy.

时间窗: During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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