Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- 13CO2/12CO2 ratio
研究概览
简要总结
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
详细描述
- Informed consent will be obtained from all patients prior to enrollment.
- The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
- This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
- All patients will undergo AFP and US if they do not have results within the past three months.
- If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
- For all patients, a case report form will be completed.
- All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
- If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
- All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
- If available, all additional MRI/CT/US results will be recorded within the patient's CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- •Any patients with chronic liver disease at risk for HCC.
- •Age ≥ 18 years.
- •Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
- •Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
排除标准
- •Any patients with chronic liver disease at risk for HCC.
- •Age ≥ 18 years.
- •Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period.
- •Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
- •Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
- •Women who are pregnant or breast feeding.
- •Patient taking drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine.
- •Patient, based on the opinion of the investigator, should not be enrolled into this study.
- •Patient unable or unwilling to sign informed consent.
- •Patients that are participating in other clinical trials evaluating experimental treatments or procedures
研究组 & 干预措施
HCC positive
Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.
干预措施: ¹³C-Octanoate Breath Test (Device)
HCC negative
Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.
干预措施: ¹³C-Octanoate Breath Test (Device)
结局指标
主要结局
13CO2/12CO2 ratio
时间窗: 60 minutes
次要结局
未报告次要终点