Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard.
研究概览
简要总结
The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI) combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0 Tesla (T) MR scanner.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient must have clinically suspected or biopsy proven prostate cancer. If a patient has been diagnosed with prostate cancer an official report of biopsy from MSKCC or outside site is required. All outside pathology reports will be confirmed at MSKCC.
- •For those patients who have undergone prostate biopsy it is recommended that the interval between biopsy and protocol MRI/MRSI should be at least 8 weeks.
- •Patient is a potential surgical candidate for treatment of prostate cancer
- •Patient is willing to undergo an endorectal MRI/MRSI exam on the 3.0T MR scanner
排除标准
- •Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- •Patients who are unwilling or unable to undergo MRI/MRSI (including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- •Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease, patients with severe hemorrhoids, patients who have had prior radiation to the pelvis to treat a malignancy, or patients who have had minor rectal surgery within the previous 8 weeks.
- •Patients with an allergic reaction to latex.
- •Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/MRSI.
研究组 & 干预措施
1
Patients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. For those patients who have undergone prostate biopsy it is recommended that this should be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete.
干预措施: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging (Other)
结局指标
主要结局
To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard.
时间窗: 3 years
次要结局
- To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.(3 years)
- To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.(3 years)