NCT00307866已完成3 期
A Prospective, Multicenter, Phase III b Clinical Study to Evaluate the Effectiveness of Unenhanced and SH U 555A (Resovist) Enhanced MRI, Compared to Contrast-Enhanced Dual-Phase Spiral CT in Assessing the Correct Final Therapy-Deciding Diagnosis, in Patients With Primary or Secondary Hepatic Malignancies.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 218
- 试验地点
- 19
- 主要终点
- To assess the proportion of correct final, therapy deciding diagnosis based on unenhanced plus SH U 555 A enhanced MR imaging compared to contrast-enhanced dual-phase spiral CT.
研究概览
简要总结
Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Present with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment. There should not be more than five liver lesions on type visualized on CT.
- •The patient should be in a condition that allows subsequent treatment.
- •Be willing and able to continue study participation following administration of SH U 555 A to ensure completion of all procedures and observations required by the trial protocol.
- •Sign and date fully informed consent prior to entry into the study.
排除标准
- •Patients under 18 years of age.
- •Patients weighing less than 35 kg.
- •Patients who have received any investigational drug within the 30 days prior to entering this study.
- •Patients who have previously entered this study or any other study performed with SH U 555 A.
- •Women who are pregnant or who are of childbearing potential and have not had a negative urine pregnancy test immediately prior to the administration of SH U 555 A. The urine pregnancy test should be performed in accordance with the manufacturer's recommendations.
- •Lactating women.
- •Patients who have any contraindication to MRI examination.
- •Patients who have received any contrast material in the 24 hours prior to SH U 555 A injection, or who are scheduled to receive any contrast material within 24 hours afterwards. (In the case of any liver specific agent (e.g. MnDPDP, SPIOs, Gd-BOPTA) this will be extended to 14 days prior to the study).
- •Patients who have received Lipiodol contrast material at any time in the past or are scheduled to receive this during the study period.
- •Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery).
- •Patients scheduled for liver biopsy within 24 hours, or who had a biopsy within the 24 hours prior to planned SH U 555 A injection.
- •Patients who are scheduled for, or are likely to require, surgery within 24 hours after SH U 555 A injection.
- •Patients with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- •Patients with known hypersensitivity to any of the ingredients of SH U 555 A.
- •Patients with already clear op-indication
结局指标
主要结局
To assess the proportion of correct final, therapy deciding diagnosis based on unenhanced plus SH U 555 A enhanced MR imaging compared to contrast-enhanced dual-phase spiral CT.
次要结局
- To assess the number, size , location and character of liver lesions.
- To assess the diagnostic confidence of MRI and CT.
- To assess the proportion of changed therapeutical decisions.
- To assess sensitivity and specificity of MRI and CT.
- To assess safety and tolerability of SH U 555 A administration.
研究者
研究点 (19)
Loading locations...
相似试验
撤回
不适用
Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable EventsHepatocellular CarcinomaNCT01963949University of Texas Southwestern Medical Center
Unknown
不适用
Clinical Trial of Radiotherapy in Treating Primary Hepatocellular CarcinomaPrimary Hepatocellular CarcinomaNCT03614546The Third Xiangya Hospital of Central South University200
撤回
2 期
Response of Hepatic Tumors to RadioembolizationLiver MetastasisHepatocellular CarcinomaIntrahepatic CholangiocarcinomaNCT01775280University of Zurich
招募中
不适用
Early detection of hepatic metastasis in follow-up high-risk colorectal carcinomaNL-OMON20752oordwest Ziekenhuisgroep Wilhelminalaan 12 1815 JD Alkmaar174
已完成
不适用
Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)Hypertension, PortalNCT03138915Nanfang Hospital, Southern Medical University385