NCT06216743尚未招募不适用
PRE- MISTIC: MRI and Cine Imaging to Improve Staging of Tumors in the Colon
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.
研究概览
简要总结
At this moment, we use CT and endoscopy to clinically stage colon tumours. Unfortunately, the combination of these imaging techniques is highly inaccurate. 40% of advanced pathological colon tumours (so called T4 tumours) are not staged as a T4 tumour pre-operatively. Preoperative or neoadjuvant chemotherapy (NAC) has improved outcomes in other gastrointestinal cancers and seems to be a promising pretreatment for colon tumours. To implement NACin colon tumours, we first need to stage the colon tumours with much higher accuracy. MRI sequences and cine imaging hold promise to provide more accurate staging of colon tumours.
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 clinical suspicion for T3 or T4 tumor based on standard clinical work-up with endoscopy and CT-scan
- •Age > 18 years
- •WHO Performance status of 0-2
排除标准
- •Patients with contraindications for MRI
- •Patients with clinical contraindications to undergo colon surgery
- •Patients receiving neoadjuvant therapy prior to surgery
- •Patients with known allergy to iodine or gadolinium contrast
- •Patient with contra-indication for contrasts based on kidney failure Neoadjuvant therapy is currently not the standard of care for advanced colon carcinoma, and applied only in selected cases or as part of a clinical trial. Because neoadjuvant therapy could result in tumor regression, thus impacting the gold standard of histological examination, patients selected for neoadjuvant therapy are excluded from this study.
结局指标
主要结局
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.
时间窗: 6 weeks
次要结局
- Sensitivity and specificity of different MRI sequences, including diffusion weighted imaging, to diagnose N2 disease, as compared to the golden standard of histological examination.(6 weeks)
- Establishing an MRI Protocol that is optimized for the clinical staging of colon tumors(6 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
MRI Staging in Colon CancerColon CancerNCT04391933Vejle Hospital130
Unknown
不适用
EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot StudySuspicion of Tumor of the Small IntestineNCT02872623CHU de Reims40
已完成
不适用
The National CT Colonography TrialColorectal CancerNCT00084929American College of Radiology Imaging Network2,600
已完成
不适用
MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?Rectal CancerLiver MetastasesNCT03463616Sahlgrenska University Hospital, Sweden320
招募中
不适用
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid CancersColon, SigmoidMagnetic Resonance ImagingGeneral SurgeryColorectal NeoplasmsCancerNCT02222844Imperial College London244