Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Standard uptake value (SUV) measured as percent injected dose per cc
研究概览
简要总结
This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.
详细描述
PRIMARY OBJECTIVES:
I. Establish the avidity of desmoid tumors on 18F-FES PET/CT imaging. II. Correlate 18F-FES PET avidity with degree of estrogen receptor (ER) expression by immunohistochemistry (IHC).
OUTLINE:
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
After completion of study, patients are followed up for 30 days.
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
- •Patients with biopsy-proven extra-abdominal desmoid tumors
- •Not currently on estrogen medication for birth control, menopause, or other reason
- •No anti-estrogen therapy for desmoid tumor within the past 6 months
- •Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included
排除标准
- •Pregnancy or nursing patients
- •Patients who do not wish to participate
研究组 & 干预措施
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
干预措施: F-18 16 Alpha-Fluoroestradiol (Drug)
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Standard uptake value (SUV) measured as percent injected dose per cc
时间窗: Initial visit, average within 24 hours of imaging
Data will be summarized graphically and numerically. Continuous variables (e.g. SUV) will be summarized using the mean, standard deviation, and a 5 number percentile summary set (minimum, p25, p50, p75, and maximum). The Spearman correlation statistic will be used to estimate the magnitude of a linear association between SUV and IHC measures. Ninety-five percent confidence intervals will be calculated for all point estimates.
次要结局
- IHC staining intensity in tissue samples(Within 4 weeks of imaging done at initial visit, day 1)
研究者
Ashish Patel
Principal Investigator
Vanderbilt-Ingram Cancer Center