Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
研究概览
简要总结
This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging.
II. To identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
OUTLINE:
Patients receive 68Ga-PSMA intravenously (IV) over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
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 either an imaging diagnosis of Hepatocellular carcinoma (HCC) by Computed Tomography (CT) or Magnetic Resonance Imaging MRI (Liver Imaging Reporting and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- •Subjects who may undergo hepatic surgical resection, liver transplant, or hepatic locoregional therapy (LRT) (e.g., ablation, embolization, etc.)
- •No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm). Patients that have been previously treated with HCC, but have new or reoccurring untreated lesions, are included in the study.
- •Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.
排除标准
- •Patients requiring emergent surgery for a ruptured/bleeding HCC
- •Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to positron emission tomography [PET]/MRI)
- •Patients with glomerular filtration rate (GFR) < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury
- •Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan
- •Patients with higher than the weight/size limitations of PET/MRI or PET/CT scanner
- •Subjects with history of allergic response to Eovist or Gadavist
- •Subjects with known history of claustrophobia
- •Subjects with GFR < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury
- •Subjects with a history of severe hypersensitivity to Eovist or Gadavist
- •Patients with contraindication to MRI (relevant to PET/MRI):
- •Patients who have a heart pacemaker
- •Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
- •Patients who have implanted devices with magnets
- •Patients who have other implanted electronic devices
- •Patients who have deep brain stimulator
- •Patients who have vagal nerve stimulator
- •Patients with cochlear (ear) or auditory implants
- •PSMA PET/CT will be an alternative in this study for patients who are unable to undergo PET/MRI for any reason but are otherwise eligible for the study.
研究组 & 干预措施
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
干预措施: Gallium Ga 68 Gozetotide (Drug)
结局指标
主要结局
Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
时间窗: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET. Grade 1 indicated uptake less than normal liver. Grade 2 indicated uptake equal to normal liver. Grade 3 indicated uptake greater than normal liver. Grade 4 indicated uptake greater than spleen or kidneys. High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
Semi-Quantitative 68Ga-PSMA-11 PET Standardized Uptake Value (SUV) Metrics in HCC Lesions With High PSMA Uptake
时间窗: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
Semi-quantitative PET metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were maximum SUV (SUVmax) and mean SUV (SUVmean).
Semi-Quantitative 68Ga-PSMA-11 PET Tumor-to-Liver Background Ratio (TBR) Metrics in HCC Lesions With High PSMA Uptake
时间窗: Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
Semi-quantitative PET tumor-to-liver background ratio (TBR) metrics were calculated in HCC lesions showing high qualitative PSMA uptake using gradient-based volume-of-interest segmentation. Reported metrics were TBRmax and TBRmean.
次要结局
未报告次要终点
研究者
Ajit H. Goenka, MD
Principal Investigator
Mayo Clinic