Imaging of the Prostate Gland Using High Field Strength 3T MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
研究概览
简要总结
In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which is a procedure to take pictures of body structures by using a strong magnetic field and radio waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla number means the magnet has stronger pull. Standard magnetic resonance imaging of the prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna) inserted into the body due to the limitations using an external body coil at this magnet strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of creating a signal twice as strong that can be received by the antennas, resulting in better pictures. The goal of this study is to make the MRI procedure more comfortable for patients by using an external coil instead of an endorectal coil. With this study, researchers also want to help patients' health care teams, the surgeons in particular. Researchers will assess the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external body coil on helping doctors decide which approaches to disease therapy might be best for patients as well as correlate patients' study images with all other clinical imaging
详细描述
PRIMARY OBJECTIVES:
I. To assess the impact of prostate MRI, without an endorectal coil, done at 3-Tesla on surgical management. This would be performed by examining the agreement of lesion location based on the MRI compared to the lesion location based on pathology and/or surgery and local extent of the disease, i.e. involvement of contiguous organs and local lymph nodes, based on the MRI compared to the local extent based on pathology and/or surgery.
II. To test the reproducibility of functional MRI (dynamic-contrast enhanced [DCE_MRI] MRI, magnetic resonance [MR] spectroscopy and diffusion-weighted MRI).
SECONDARY OBJECTIVES:
I. To assess the usefulness of MRI data in treatment planning for radiation therapy, and to test the feasibility of amide-proton-transfer MRI in prostate cancer detection.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason's score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
- •Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board
- •Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study
排除标准
- •Patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
- •Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
- •Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure
- •Patients with permanent tattoo eye liner (may contain metallic coloring)
- •Patients that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
- •Patients that exhibit noticeable anxiety and/or claustrophobia
- •Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
- •Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
- •Patients with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI
- •Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)
- •Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
结局指标
主要结局
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
时间窗: Up to 6 years
The primary outcome in this study is the agreement in tumor staging between pathology and 3 Tesla MRI.
次要结局
未报告次要终点
研究者
Michael V Knopp MD PhD
Principal Investigator
University of Cincinnati