PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- T2 relaxation time using PET/MRI fusion
研究概览
简要总结
The primary objective of this study is to explore feasibility of testis functionality assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the three-dimensional structure of normal testis, the levels of specific elements and compounds in the tissues (which can only be found via these imaging techniques), and the directionality (and alterations in directionality) of tissue structure. Investigators hope to develop hypothesis that will in turn suggest bio-markers to be explored in subsequent clinical trials.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Men with proven paternity desiring vasectomy who are over 18 years of age.
排除标准
- •Bilaterally absent testes, unilaterally or bilaterally undescended testes
- •Patients who have proven azoospermia or no proven paternity
- •Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for > 45 minutes.
- •Presence of pacemaker/IImplantable Cardioverter Defibrillator (ICD) or perfusion pumps
- •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
- •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
- •All women are excluded as such patients do not have the relevant anatomy being considered in this study
- •Anyone from a vulnerable population will be excluded from the study
结局指标
主要结局
T2 relaxation time using PET/MRI fusion
时间窗: 2 Months
Metabolite concentration using PET/MRI fusion
时间窗: 2 Months
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
时间窗: 2 Months
Spectroscopy of the testis using PET/MRI fusion
时间窗: 2 Months
次要结局
未报告次要终点