FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Continuous standardized uptake values (SUV)
研究概览
简要总结
The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation
详细描述
PRIMARY OBJECTIVES:
I. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 [FDG[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.
OUTLINE:
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.
After completion of study treatment, patients are followed up for 2 years.
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
- Single
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
- •Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
- •Undergone clinical FDG PET/CT scan within 14 days of enrollment
排除标准
- •Prisoners
- •Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose > 180 mg/dl)
- •Serious infection within 14 days of enrollment
- •Known hypersensitivity to methylprednisolone
- •Viral skin lesions
- •Immunocompromised ANC(absolute neutrophil count < 1000/microliter)
- •Pregnant/nursing
- •History of tuberculosis or systemic fungal disease
- •History of steroid psychosis
- •Current peptic ulcer disease or diverticulitis
- •Corticosteroid use within 14 days of enrollment (including inhaled steroids)
研究组 & 干预措施
Diagnostic (methylprednisolone and FDG PET/CT scan)
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
干预措施: methylprednisolone (Drug)
Diagnostic (methylprednisolone and FDG PET/CT scan)
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
干预措施: fludeoxyglucose F 18 (Radiation)
Diagnostic (methylprednisolone and FDG PET/CT scan)
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
干预措施: positron emission tomography (Procedure)
Diagnostic (methylprednisolone and FDG PET/CT scan)
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
干预措施: computed tomography (Procedure)
结局指标
主要结局
Continuous standardized uptake values (SUV)
时间窗: Within 1-14 days of first scan
The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history.
次要结局
未报告次要终点