A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Brain structural connectivity
研究概览
简要总结
This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other places in the body (non-metastatic) and who have or have not received androgen deprivation therapy (ADT). The MRI machine uses a strong magnet and radio wave to make images of the inside of the body. A stronger magnetic field allows greater signals and more detailed visualization of the structure and function of human body. Giving 7 Tesla MRI may help doctors learn if patients that receive ADT show more signs of cognitive dysfunction or brain fog compared to patients to patients that do not receive ADT.
详细描述
PRIMARY OBJECTIVES:
I. Observe longitudinal changes in structural connectivity using T1-weighted and diffusion tensor MRI in men with non-metastatic prostate cancer on current ADT versus those who were not.
II. Observe longitudinal changes in brain functional connectivity using resting-state functional (rsf) MRI.
III. Observe longitudinal changes in brain metabolic profiles evaluated by MR spectroscopy (MRS).
IV. Exploratory assessment of correlation between testosterone and prostate specific antigen (PSA) levels with MRI measures and cognitive measures.
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
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent
- •Group 1 (G1): Non-metastatic biopsy-proven prostate cancer patients on current ADT and
- •Group 2 (G2): Demographically (age, cancer stage) matched non-metastatic biopsy proven prostate cancer patients without a history of ADT
- •Ability to undergo imaging procedure without any form of sedation
- •Ability to complete brief cognitive testing on iPad
排除标准
- •History of dementia or other neuropsychiatric disease
- •History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
- •Standard contraindications for MRI:
- •Prior work as a machinist or metal worker, or history of metal being removed from the eyes,
- •Cardiac pacemaker or internal pacing wires,
- •Non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or
- •Claustrophobia, or uncontrollable motion disorder
- •Currently active second malignancy
- •Any significant cardiovascular conditions (New York Heart Association [NYHA]) class III or IV congestive heart failure, myocardial infarction within 6 months, unstable angina, pacemaker); or
- •Renal disease with calculated creatinine clearance of < 45 ml/min
结局指标
主要结局
Brain structural connectivity
时间窗: Up to 1 year
Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity
时间窗: Up to 1 year
Will be measured using resting-state functional MRI.
Brain metabolic profiles
时间窗: Up to 1 year
Will be evaluated by MR spectroscopy.
次要结局
未报告次要终点