A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of patients with identified tumor lesion sites
研究概览
简要总结
The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular Carcinoma, gastroenteropancreatic neuroendocrine neoplasms also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GET patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.
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 newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy
- •Available tissue specimen to conduct PSMA expression profiling
- •Male/female, above 18 years old
- •Patients must provide written informed consent
- •Patients must be willing to comply with study procedures and available for follow-up examinations
排除标准
- •Curative setting
- •Not sufficient tumor tissue available
- •Male Patients: No prostate carcinoma
- •Other malignant neoplasms in patient's history
- •Pregnancy or Breastfeeding
- •Contraindications for PET/CT
结局指标
主要结局
Number of patients with identified tumor lesion sites
时间窗: 24 months
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.
True positive rate per patient specimen
时间窗: 24 months
The probability of GET is given when immunhistochemistry test is positive.
True positive rate per patient
时间窗: 24 months
The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
True positive rate per patient specimen
时间窗: 24 months
The probability of GET is given when immunhistochemistry test is positive.
True positive rate per patient
时间窗: 24 months
The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
Number of patients with identified tumor lesion sites
时间窗: 24 months
To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.
次要结局
- Ex-vivo PSMA expression(24 months)
- PSMA uptake on 18F-PSMA-1007 PET(24 months)