Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
Primary objective:
To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.
Secondary objectives:
- To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
- To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
- To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.
详细描述
According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard.
Therefore, we conduct this trial to identify the ability of [11C]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •40-85 years of age
- •Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia
- •Able to tolerate [11C]Choline PET scan and MRI scan
- •Written informed consent from the patient
排除标准
- •Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months.
- •History of AIDS in the period prior to the screening.3
- •Contraindications to [11C]Choline PET/MR scans
- •Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH
- •Metallic prosthesis of the hip or pelvic region
- •Renal function impairment with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
- •Claustrophobia
- •Medical drugs with choline
- •Previous allergy to carbon-labeled radionuclide
- •Active other malignancy within the last 2 years
- •Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
- •Prisoners or patients with mental illness
结局指标
主要结局
Diagnostic Accuracy
时间窗: 1 year
sensitivity, specificity, accuracy
次要结局
未报告次要终点
研究者
Gigin Lin
Associate Professor
Chang Gung Memorial Hospital