18F-FMISO-PET, 18F-FDG-PET/CT, DWI-MRI and DCE-MRI Scans as Predictors of Response to Radiotherapy +/- Chemotherapy in Patients With Anal Cancer.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy (Cisplatin and 5-FU).
详细描述
The study involves tree MRI sessions, two FDG-PET-CT sessions and one FMISO-PET session. The FMISO-PET session is presently not carried out because of delivery problems. The production of 18F-fluoromisonidazol at The Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Herlev, Denmark has not jet been approved by the Danish Medicines Agency.
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
- •Histological confirmation of invasive primary squamous cell carcinoma of the anal canal or perianal region.
- •TNM stage T1-4, N0-3, M0-1
- •Treatment with curative intent
- •Age > 18 years
- •Able to provide informed consent
排除标准
- •Contraindication to MRI imaging
- •Cardiac pacemaker
- •Major obesity
- •Serious claustrophobia
- •Other malignant disease (except non-melanoma skin cancer) in a period of 5 years prior to imaging study
- •Poorly regulated diabetes mellitus despite insulin
- •Pregnancy
- •Breast feeding
- •Known allergy to iv contrast agent
- •Major psychiatric illness which would prevent participation in the imaging study
- •Infectious wounds on the legs
- •Unacceptable kidney function
- •Major language difficulties which would prevent participation in the imaging study
结局指标
主要结局
Tumor response
时间窗: 6-8 weeks post radiation
* Primary tumor 18-F-deoxyglucose (FDG) uptake before radiation and during week 3 of radiation. * Primary tumor apparent diffusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation * Primary tumor perfusion coefficient before radiation and during week 3 of radiation and 6-8 weeks post radiation * Primary tumor 18-F-Fluoromisonidazol (FMISO) uptake before radiation
次要结局
未报告次要终点