EUCTR2012-000952-32-Outside-EU/EEA进行中（未招募）不适用
Open-label, multi-center study to evaluate the safety, efficacy, and plasma gadolinium concentrations after an intravenous injection of 0.1 mL/kg body weight Eovist/Primovist for enhanced magnetic resonance imaging (MRI) of the liver in children 0 to 2 months of age
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 0-2 months (must be gestational age 37 to 41 weeks) - Scheduled to undergo routine contrast-enhanced liver MRI - Able to comply with the study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period - If receiving chemotherapy, may have a change in treatment during the study period - Contraindication for MRI - Renal insufficiency (estimated glomerular filtration rate < 80% of age-adjusted normal mean value using the Schwartz formula) - Acute renal failure - Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)
研究者
相似试验
进行中（未招募）
1 期
An open-label, multicenter study to assess the safety ofRO5185426 in patients with metastatic melanomaPatients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.MedDRA version: 15.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023526-21-BEF. Hoffmann-La Roche Ltd.3,300
进行中（未招募）
1 期
An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanomaPatients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023526-21-DKF. Hoffmann-La Roche Ltd.2,000
进行中（未招募）
1 期
An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanomaPatients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.MedDRA version: 17.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2010-023526-21-IEF. Hoffmann-La Roche Ltd.3,300
进行中（未招募）
1 期
An open-label, multicenter study to assess the safety of RO5185426 in patients with metastatic melanomaEUCTR2010-023526-21-DEF. Hoffmann-La Roche Ltd.3,300
进行中（未招募）
1 期
An open-label, multicenter study to assess the safety ofRO5185426 in patients with metastatic melanomaPatients with histologically confirmed metastatic melanoma harboring the BRAF V600 mutation as determined by the cobas® 4800 BRAF V600 Mutation Test.MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023526-21-SEF. Hoffmann-La Roche Ltd.3,300