NCT00946140已完成不适用
Motion Correction in Dynamic Contrast Enhanced MRI in Ovarian Cancer: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Development of automated motion correction algorithms and new functional methods that permit use of DCE-MRI in primary or metastatic tumors of the ovaries.
研究概览
简要总结
The purpose of this study is to develop new image analysis method using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part of the standard care for ovarian cancer. In this method, a contrast agent is used to make ovarian cancer visible during imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with measurable disease with evidence of at least one uni-dimensionally measurable tumor (> 1 cm) by CT or MRI scan according to RECIST (Response Evaluation Criteria in Solid Tumors) that the tumor has not been initially treated with surgery or radiation therapy.
- •Patients who will start treatment with bevacizumab combined with or without cytotoxic chemotherapy within 14 days from signing consent. Patients treated on an approved IRB therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible.
- •Patients with histologically confirmed ovarian epithelial cancer including primary peritoneal and fallopian tube adenocarcinoma.
- •Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception.
- •Patients who are older than 21 years of age.
- •Patients who are able to understand and sign informed consent.
排除标准
- •Patients treated on an approved IRB therapeutic protocol with a blinded arm of bevacizumab or placebo are not eligible (IRB 07-078 and IRB 05-138).
- •Patients with cardiac pacemakers.
- •Patients with certain prosthetic devices and implants who are not compatible with the high magnetic field present in the DCE-MRI scanners.
- •Patients who have experienced a prior adverse reaction to the gadolinium complex contrast agent used in DCE-MRI imaging and who don't meet criteria for creatinine and nephrogenic systemic sclerosis risk per guidelines of department of radiology.
- •Patients prone to claustrophobia.
- •Patients on dialysis.
结局指标
主要结局
Development of automated motion correction algorithms and new functional methods that permit use of DCE-MRI in primary or metastatic tumors of the ovaries.
时间窗: 2 years
次要结局
- Testing of new methods using the DCE-MRI data sets for comparing changes in tumor perfusion with and without motion correction post anti-angiogenic therapy in ovarian cancer.(2 years)
研究者
研究点 (1)
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