A Prospective Study of Ga-68 Dolacga Scintigraphy to Evaluate Liver Reserve Function in Patients With Hepatocellular Carcinoma Before and After Proton Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.
研究概览
简要总结
This is a single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy.
详细描述
This is a single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy.
This trial will enroll 10 eligible subjects. All subjects will provide informed consent before any study procedures are performed. Screening procedures (visit 1) will occur within 21 days prior to imaging visit (visit 2) and will include: inclusion/exclusion criteria check, pregnancy test (if applicable), vital signs, laboratory tests, electrocardiogram (ECG) and establishment of baseline characteristics. Primovist MRI will occur within 14 days prior to imaging visit (visit 2) and 1 week after imaging visit (visit 4), and will be performed according to standard procedure of study site.
The baseline characteristics include medical/medication history, fibrosis index, Child-Pugh score and classification, MELD score, liver oncology diagnosis, tumor size, preoperative treatments (portal vein embolization, transarterial chemoembolization, transarterial embolization or biliary drainage), existence of thrombosis (portal vein thrombosis or hepatic vein thrombosis). The liver tissue fibrosis index FIB-4 will be measured to assess the morphological changes.
During the imaging session (visit 2, Day 1; visit 4, Day 84±3), a catheter will be placed for intravenous (IV) administration of Ga-68 Dolacga. Subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga-68 Dolacga. A PET/CT scan will be kinetically performed for 60 minutes immediately after IV injection.
The measurement of liver reserve is the primary endpoints of this study and measurement will be evaluated by Ga-68 Dolacga PET. The measurement of liver reserve will be performed at visit 2 and visit 4 of this study for all subjects. Adverse events will be continuously monitored during the imaging session.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hepatocellular carcinoma and scheduled to have the PBT.
- •20~80 years old
- •Performance status: ECOG 0-1
- •Child-Pugh class A
排除标准
- •Massive or uncontrolled ascites
- •Concurrent with other malignancy
- •Under pregnancy or breastfeeding
- •With distant metastasis
- •Allergic to investigational drug(s) or similar drug(s)/ formulation(s);
- •Known hypersensitivity to PRIMOVIST
- •Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m^2)
- •General PET and MRI exclusion criteria
- •Can't follow our follow-up schedule because of any reason
研究组 & 干预措施
Ga-68 Dolacga Injection
Ga-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus
干预措施: Ga-68 Dolacga Injection (Drug)
结局指标
主要结局
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.
时间窗: Visit 2 (Day 1)
The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."
Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients after proton therapy.
时间窗: Visit 4 (Day 84±3)
The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."
次要结局
- Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects reporting clinically significant changes in hematological tests(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects reporting clinically significant changes in urinalysis(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects with body temperature abnormalities(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects with clinically significant changes in Heart Rate(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects reporting clinically significant changes in serum biochemical tests(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Number of subjects with clinically significant changes in electrocardiogram(ECG)(from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2))
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(91 days)