2024-514831-34-00招募中3 期
A prospective, open-label, single-center phase 3 superiority study to assess the clinical nodal stage (cN-stage) accuracy of ferumoxtran-10 -enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathologic pN-stage in newly diagnosed rectal cancer (RC) patients, scheduled for direct surgery or short course radiotherapy prior to surgery.
Varsinais-Suomen hyvinvointialue1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage of newly-diagnosed RC patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntarily given and written informed consent. • Males and females over 18 years of age. • Newly diagnosed rectal cancer patients scheduled for direct surgery or SCRT. • Female subjects must be not of child-bearing potential, defined as postmenopausal for at least 1 year or surgically sterile. • Women of childbearing potential (WOCBP) can be included if they take precautions against pregnancy during the study and for at least 3 months thereafter.
排除标准
- •Subjects unable to provide written informed consent • Age under 18 • Metastatic disease • T1-disease • Allergy to Ferumoxtran-10 or known hypersensitivity to Ferumoxtran-10 or its components • Known history of drug allergy (including hypersensitivity) to other parenteral iron products • Prior severe allergic reactions, including severe asthma and acute drug-induced severe reactions • Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple iron transfusions for any reason) • Breastfeeding or pregnant women • Women of childbearing potential who are not willing to use effective contraceptive precautions against pregnancy • Prior abdominopelvic radiation • Prior abdominopelvic malignancies • Patients deemed too frail for surgery • Contraindications for MRI (ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.)
结局指标
主要结局
Accuracy
Accuracy
次要结局
- positive predictive value, negative predictive value, sensitivity, specificity.
研究者
Jaakko Vanhatalo
Scientific
Varsinais-Suomen hyvinvointialue
研究点 (1)
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