An Open-label, Comparative Phase II Clinical Trial to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve Among Scheduled Surgery Operation Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))
研究概览
简要总结
This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry and indocyanine green retention test for measurement of liver reserve among scheduled surgery operation patients.
详细描述
This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry (CTV) and indocyanine green retention test (ICGR15) for measurement of liver reserve among scheduled surgery operation patients. The goal is to enroll 30 eligible subjects scheduled for surgery operation.
CTV and ICGR15 will occur within 7 days prior to the imaging visit for all eligible subjects. During the imaging visit (visit 2, Day 1), subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga68-Dolacga Injection. Ga68-Dolacga PET will be kinetically performed 60 minutes immediately after iv injection.
Two follow-up visits (visit 3 at Day 7±2 and visit 4 at Day 14±2) will be conducted to confirm subject well-being and to collect information about any new adverse events (if any).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled operation subjects with diagnosed hepatic carcinoma. The eligibility criteria for operation refer to protocol Appendix II: Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma in Chang Gung Memorial Hospital;
- •Subjects without ascites or with controllable ascites;
- •Serum total bilirubin level < 2.0 mg/dL;
- •Written informed consent must be obtained before any assessment is performed.
- •Male or female subjects aged 20 or above, inclusive, at date of consent.
排除标准
- •Presence of distant metastases;
- •A body weight loss of >10% during the 6 months before operation;
- •Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease;
- •Cholangiocarcinoma;
- •General PET exclusion criteria;
- •Pregnant women, lactating or breast-feeding women;
- •Patient who can't be followed up for any reason.
研究组 & 干预措施
Ga68-Dolacga Injection
Ga68-Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
干预措施: Ga68-Dolacga Injection (Drug)
结局指标
主要结局
Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))
时间窗: within 7 days prior to Day 1
The liver reserve obtained from computer tomography volumetry (CTV) is expressed in "remnant volume rate (%)."
Correlation of the remnant volume rate determined by CTV with conventional liver function tests
时间窗: from pre-dose to Day 1
The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\^3/μL), ICGR15 (%), Child-Pugh classification (Class A to Class C), MELD score.
Correlation of the ICGR15 with the conventional liver function tests
时间窗: from pre-dose to Day 1
The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\^3/μL), Child-Pugh classification (Class A to Class C), MELD score.
Measurement of future liver remnant function rate (FLRF%)
时间窗: visit 2 (Day 1)
The future liver remnant function rate (FLRV%) is calculated by dividing the uptake in the future remnant liver volume by the uptake in the total liver volume from Ga68-Dolacga PET and expressed as %.
Measurement of future liver remnant volume rate (FLRV%)
时间窗: within 7 days prior to Day 1
The future liver remnant volume rate (FLRV%) is calculated by dividing the future remnant liver volume by the total functional liver volume from CTV and expressed as %.
Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)
时间窗: visit 2 (Day 1)
The liver reserve obtained from Ga68-Dolacga PET is expressed in "percentage of injection dose (%ID)."
Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with conventional liver function tests
时间窗: from pre-dose to Day 1
The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\^3/μL), ICGR15 (%), Child-Pugh classification (Class A to Class C), MELD score.
次要结局
- Correlation of the ICGR15 with the fibrosis indices(from pre-dose to Day 1)
- Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with the fibrosis indices(from pre-dose to Day 1)
- Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure(from pre-dose to 14±2 days post dose)
- Number of subjects with body temperature abnormalities(from pre-dose to 14±2 days post dose)
- Number of subjects with clinically significant changes in Heart Rate(from pre-dose to 14±2 days post dose)
- Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF(on or after postoperative day 5 (POD 5))
- Number of subjects reporting clinically significant changes in serum biochemical tests(from pre-dose to 14±2 days post dose)
- Number of subjects reporting clinically significant changes in hematological tests(from pre-dose to 14±2 days post dose)
- Number of subjects reporting clinically significant changes in urinalysis(from pre-dose to 14±2 days post dose)
- Number of subjects with clinically significant changes in electrocardiogram(ECG)(from pre-dose to 14±2 days post dose)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(14 days)
- Incidence of posthepatectomy liver failure (PHLF)(on or after postoperative day 5 (POD 5))
- Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)(on or after postoperative day 5 (POD 5))