NCT06689670招募中不适用
To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: a Prospective, Single-arm, Single-center Clinical Study
inTumo Therapeutics, Inc.2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Ablation
研究概览
简要总结
The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are:
- Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely?
- What medical problems do participants experience when receiving INT001?
Participants will:
Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary or secondary liver cancer.
- •ECOG Performance Status score of 0 - 2
- •Age ≥18 years, <100 years
- •Life expectancy of ≥3 months
- •Patient is unsuitable for surgical resection or transplantation
- •Ability of the patient to understand and sign the Informed Consent Form describing the study's nature
- •Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits
排除标准
- •Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
- •Signs of liver dysfunction: AST or ALT >5 times the upper limit of normal (ULN), Serum bilirubin level >2.0 mg/dL
- •Individuals with bleeding disorders.
- •History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
- •Patients with life-threatening serious extrahepatic disease.
- •Patients with concurrent conditions that, in the investigator's opinion, would prevent clinical benefit from the study procedure or could compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, or morbidity).
- •Significant medical or psychiatric illness.
- •Pregnant or breastfeeding women or women planning to conceive within the next 6 months.
- •Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.
- •Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.
- •Lesions that are not hypervascular on angiography.
- •Patients who do not have CT or MR imaging available at the screening visit or are unwilling or unable to undergo MRI for various reasons during the study.
结局指标
主要结局
Ablation
时间窗: MRI will be performed the day of the intervention, at 30 days and at 90 days.
Ablation of the tumor will be assessed using imaging criteria such as RECIST.
Safety
时间窗: From day 1 to day 90
Adverse events, if any, will be recorded
次要结局
- Biomarkers(Day 30 and Day 90)
研究者
研究点 (2)
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