Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Degree of PSMA uptake by HCC
研究概览
简要总结
Assess the rate and degree of PSMA uptake in patients with hepatocellular carcinoma submitted to PET/MRI scans. The objective is to evaluate its value on diagnosis and staging of HCC.
详细描述
PET/MR - PSMA have emerged as a new method and there are few studies about its role in the evaluation of hepatocellular carcinoma (HCC).
The hypothesis in this study is that PET/MRI with PSMA might have an additional value in the assessment of hepatocellular carcinoma, contributing to the diagnosis of distant metastasis and to confirm the diagnosis in undetermined nodules by the standard exams (computed tomography and magnetic resonance imaging).
Patients with hepatocellular carcinoma diagnosed by computed tomography or magnetic resonance imaging and referred to a liver transplant or surgery by clinical decision wil be submitted to a whole-body PSMA-PET/MRI and will be included in this prospective unicentric study to be conducted at Instituto do Câncer do Estado de São Paulo (ICESP) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).
All cases will be evaluated to determine the presence and degree of PSMA uptake on lesions considered as definitely HCCs by CT or MRI. The sensitivity of PSMA - PET/MR for the diagnosis of HCC will be calculated.
The added value of PSMA - PET MR on systemic staging will be calculated by the number of lesions considered suspicious for malignancy that were not detected by conventional scans.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an imaging diagnosis of HCC by a previous CT or MRI, reviewed by an abdominal radiologist
- •Patients candidates to liver transplant or surgical resection
排除标准
- •Patients with treated liver lesion without viable tumor
- •Age under 18
- •Pregnancy
- •Patients with renal insufficiency;
- •Elevated bilirubin levels (>3 mg/dL)
- •Known allergy to contrast media (gadoxetic acid) or radiotracer (PSMA);
- •Blood glucose level higher than 150 mg/dl.
- •MR contraindications (claustrophobia, cardiac pacemakers, neurostimulators, cochlear implants, and insulin pumps).
结局指标
主要结局
Degree of PSMA uptake by HCC
时间窗: 24 months
For all liver lesions diagnosed as HCC, the degree of PSMA on PET uptake will be measured and correlated with available pathology information
Diagnostic performance of PET MRI - PSMA for HCC
时间窗: 24 months
Patients with a liver lesion diagnosed as hepatocellular carcinoma by MRI or CT and candidates to surgical resection or liver transplant will be submitted to PET MRI with PSMA. Based on the presence or absence of PSMA uptake, sensitivity and specificity of PET MRI for diagnosis of the liver lesion and extrahepatic disease will be calculated.
次要结局
- Correlation of PSMA uptake and liver nodules histology(24 months)
- Presence of PSMA uptake on treated liver lesions(24 months)
研究者
Irai Santana de Oliveira
MD
University of Sao Paulo