2023-508709-26-00招募中2 期
F-18 PSMA-11 PET for Imaging and Staging of Hepatocellular carcinoma with Evaluation of Survival
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Per-lesion detection rate of F-18 PSMA-11 PET/CT, 60-90 minutes post-injection.
研究概览
简要总结
To determine the diagnostic accuracy of F-18 PSMA-11 PET/CT for the (re)staging of hepatocellular carcinoma (HCC) compared to F-18 FDG PET/CT and F-18 Choline PET/CT.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Willing and mentally legally capable to provide written informed consent
- •18 years of age or older
- •One of the following clinical scenario’s: • New diagnosis of HCC, confirmed either by biopsy or imaging using EASL/AASLD criteria, with a high risk of metastases indicated by portal invasion or a primary lesion of >5cm diameter. • Known diagnosis of HCC that requires restaging due to unexplained elevated AFP tumor markers, known metastases, impending initiation of immunotherapy, or being on the waiting list for a liver transplant.
- •Have either planned or recently undergone (within the past 4 weeks) both F-18 FDG PET/CT and F-18 Choline PET/CT scans as part of their diagnostic or staging workup for one of the above indications.
排除标准
- •Known active malignancy other than hepatocellular carcinoma.
- •History of prostate cancer
- •Active pregnancy
- •Possible pregnancy and refusal of urine pregnancy test
结局指标
主要结局
Per-lesion detection rate of F-18 PSMA-11 PET/CT, 60-90 minutes post-injection.
Per-lesion detection rate of F-18 PSMA-11 PET/CT, 60-90 minutes post-injection.
次要结局
- Overall Survival (OS) and Progression-Free Survival (PFS): Measured among subjects with PSMA-avid, FDG-avid, and Choline-avid HCC lesions, measured after completion of the 2 year follow-up for all patients.
- Tumor-to-Background Ratio: Assessed for intrahepatic HCC lesions 60-90 minutes post-injection using F-18 PSMA-11 PET/CT.
- Standard Uptake Value (SUV) Parameters: Analyzed for all HCC lesions detected 60-90 minutes post-injection with F-18 PSMA-11 PET/CT.
- Proportion of subjects with Metastatic HCC: Comparison between those detected by F-18 PSMA-11 PET/CT, F-18 FDG PET, and F-18 Choline PET, 60-90 minutes post-injection.
研究者
Robbe Waterschoot
Scientific
Universitair Ziekenhuis Gent
研究点 (1)
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