NCT05410509已完成不适用
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
研究概览
简要总结
Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Aged ≥18 years
- •Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
- •Longest tumor diameter measures 4.1-7cm
- •Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30
- •Renal cell carcinoma as part of a syndrome
- •Horseshoe kidney
- •Patient unable to undergo renal mass protocol CT or MRI
- •Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
- •Uncorrectable coagulopathy, including a platelet count of <30,000/μL and/or an international normalized ratio (INR) >2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
- •Performance status precludes enrollment as determined by the investigators
研究组 & 干预措施
RCC Participants
Experimental
Receive Trans-arterial embolization (TAE)
干预措施: Trans-arterial embolization (TAE) (Procedure)
结局指标
主要结局
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
时间窗: 30-90days post procedure
次要结局
未报告次要终点
研究者
Andrew J. Gunn
Associate Professor
University of Alabama at Birmingham
研究点 (8)
Loading locations...
相似试验
尚未招募
2 期
A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell CancerRenal Cell CarcinomaClear Cell Renal Cell CarcinomaNCT04958473Tianjin Medical University Second Hospital40
进行中（未招募）
不适用
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma Non-resectableLiver CancerHepatocellular CarcinomaNCT05953337ABK Biomedical120
尚未招募
不适用
Preoperative Arterial Embolization Before Oncologic Esophagectomy as a Technique for Ischemic Gastric ConditioningEsophageal CancerNCT06312839Centre Hospitalier Universitaire de Saint Etienne50
暂停
1 期
68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCCClear Cell Renal Cell CarcinomaNCT06649682Peking Union Medical College Hospital20
Unknown
早期 1 期
Tumor Electric Fields Treatment System for GlioblastomaGlioblastomaNCT04417933Xiangya Hospital of Central South University5