A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Brain structural connectivity
研究概览
简要总结
This study evaluates 7 Tesla (T) magnetic resonance imaging (MRI) in observing changes in the brain (neuroimaging) in testicular cancer patients who have decreased testosterone (hypogonadism) and are on testosterone (androgen) replacement therapy. Symptoms of hypogonadism can include fatigue, weakness, loss of libido, depression, poor concentration and erectile dysfunction. Some patients experience mental changes after diagnosis and treatment. There is some evidence that hypogonadism produces structural changes in the brain. The 7T MRI uses radio waves and a very powerful magnet linked to a computer to create detailed pictures of areas inside the body. This study may help researchers learn if 7T MRI can produce better images to assess the changes in the brain structure of testicular patients with hypogonadism and on androgen replacement therapy (ART).
详细描述
PRIMARY OBJECTIVE:
I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal men with testis cancer being treated with androgen replacement therapy.
OUTLINE: This is an observational study.
Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI. Additionally, patients undergo blood sample collection at screening and at 12 months after baseline MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males age >= 18 years
- •Diagnosed with germ cell tumor of the testis (seminoma or non-seminoma) and treated with radical orchiectomy
- •Diagnosed with hypogonadism and started androgen replacement therapy 6 months prior (+/- 2 weeks)
- •Ability to understand and the willingness to sign a written informed consent
- •Ability to undergo imaging procedure without any form of sedation
排除标准
- •History of any neuropsychiatric disease
- •History of narcotic use or psychiatric medications
- •History of ART prior to current ART regimen
- •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
- •Current active second malignancy
结局指标
主要结局
Brain structural connectivity
时间窗: At baseline and 12 months
Measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).
Brain functional connectivity
时间窗: At baseline and 12 months
Measured using resting-state functional MRI.
Brain metabolic profiles
时间窗: At baseline and 12 months
Evaluated by MR spectroscopy.
Brain perfusion
时间窗: At baseline and 12 months
Evaluated by arterial spin labeling MRI.
次要结局
未报告次要终点