NCT01958931已完成不适用
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
Fresh Medical Laboratories1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2007年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- ProLung Test utility in lung cancer
研究概览
简要总结
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
详细描述
This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung Test when used to evaluate patients with a positive CT scan for lung cancer.
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
- 否
入选标准
- •Subject is male or female, age 18 or above.
- •If female, subject
- •is of non-childbearing potential meaning permanently sterile, or
- •is one year post-menopausal; or
- •is not pregnant as confirmed by negative urine pregnancy test and using adequate birth control at time of screening.
- •Subject presents with one or more of the following clinical symptoms or suspicious radiological finding(s):
- •Persistent cough
- •Hoarseness
- •Shortness of breath
- •Sputum streaked with blood
- •Unexplained recent weight loss
- •Recurrent pneumonia or bronchitis
- •Chest pain
- •Abnormal chest radiograph
- •Subject has undergone a CT scan of the lungs within 44 days of measurement that indicates one or more non-calcified nodules (NCN) or lung masses suspicious for lung cancer.
- •Subject is capable of understanding and agreeing to fulfill the requirements of this protocol.
- •Subject has signed the IRB/IEC approved informed consent form.
排除标准
- •Subjects who meet one or more of the following criteria may not be enrolled in this Study:
- •Subject has a pacemaker or other implanted electronic device.
- •Subject with diagnosed malignancy within the past 5 (five) years except for non-melanoma skin cancer.
- •Subject with significant systemic diseases including uncontrolled diabetes, severe heart failure, uncontrolled hypertension, myocardial infarction and/or auto-immune conditions within the prior 3 (three) months.
- •Subject taking systemic corticosteroid medication (except for inhaled) within 14 days prior to measurement session.
- •Subject has had an invasive medical procedure that involves the thoracic cavity within 30 days prior to the measurement session.
- •Subject who currently abuses alcohol or drugs.
- •Subject presents with an anomalous physical or anatomical condition that precludes measurement.
- •Subject will have undergone unusually strenuous exercise within 24 hours prior to measurement session.
- •Subject who has, in the Principal Investigator's opinion, any medical condition or other circumstance that would prevent completion of this Study or interfere with analysis of the Study results.
- •Subjects who have undergone radiation and chemotherapy treatment within the past 30 days.
- •Subject receiving therapy for documented or suspected chest infection.
- •Pregnant or lactating females.
结局指标
主要结局
ProLung Test utility in lung cancer
时间窗: date of conclusive diagnosis
This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan to determine whether it is appropriate to be used in a pivotal study.
次要结局
- Safety and Tolerability of the ProLung Test(within 30 minutes of the ProLung Test)
研究者
研究点 (1)
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