Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison
研究概览
简要总结
Single centre prospective evaluation of 68Gallium(Ga68)-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). 68Gallium-FAPI-46 PET/MRI and standard contrasted multiphasic MRI imaging will be acquired in patients with radiological or histological diagnosis of HCC. The PET scan results will be compared to standard imaging to evaluate its role in lesion detection, characterisation and staging in patients with HCC.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-99 years
- •Diagnosis of HCC based on histological assessment, or meeting consensus radiological criteria for diagnosis of HCC based on American Association for the Study of Liver Diseases practice guidelines(18)
- •No prior locoregional therapy for HCC
- •Creatinine clearance > 30ml/min based on Cockcroft Gault formula
- •Able to provide informed signed consent
排除标准
- •Allergy to 68Ga-FAPI contrast agents
- •Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia
- •Weight > 150kg
- •Known active malignancy other than HCC
- •Hepatic surgery within the last 30 days.
- •Active inflammatory conditions that may affect FAPI imaging in opinion of investigator. Including but not limited to active infection, IgG4-related disease, inflammatory bowel disease,
- •Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)
研究组 & 干预措施
68Gallium-FAPI-46 PET/MRI
Patients receiving Ga68-FAPI-46 will be injected at a dose of 4mCi +/- 2mCi (0.05mCi/kg). Whole body PET scans will be acquired 45mins post injection from head to mid thighs
干预措施: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI (Drug)
结局指标
主要结局
Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison
时间窗: 1 year
Calculated as: Number of MRI detected HCC lesions with FAPI-46 uptake / number of MRI detected intrahepatic HCC lesions
次要结局
- Determine the proportion of cases whereby use of FAPI-46 PET/MRI leds to AJCC TNM/BCLC stage being, i) unchanged, ii) up-staged and iii) down-staged(1 year)
- Sensitivity estimation of 68Gallium-FAPI-46 PET/MRI in per-lesion analysis for all lesions with available surgical resection samples for histopathology assessment(1 year)