Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
To learn if MRS can effectively assess spinal cord lesions.
详细描述
Primary Objective:
Establish the feasibility and spectrum of MRS for adult patients while mapping the total spine spectrum at short TEs to allow for future comparison with patients to assess spinal cord lesions malignant potential and grade.
Secondary Objective:
Test success of the spectrum by implementing the protocol on 3 low volume LMD receiving LMD receiving CSI. This will allow us to test reproducibility of the protocol and test effect of radiation on spinal cord at different time frames. This will serve as secondary data for subsequent trials targeting functional statues after radiation and tumor grading predictability of MRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers:
- •Adults > 18 years
- •Healthy with no malignancy, demyelinating disease, back pain, degenerative disease, or spinal cord lesions.
- •Consent able patients.
- •Patients with low volume LMD to receive treatment CNS radiation:
- •Adults > 18 years old.
- •MR or CSF with evidence of LMD.
- •Patients to receive CSI as part of standard treatment of LMD disease.
- •Consent able patients, willingness and ability to comply with the study procedures.
- •No spinal cord lesions only LMD disease
- •Recruitment by radiation oncology faculty in consultation with Dr. De. . .
排除标准
- •Volunteers:
- •Age < 18 years
- •Pregnant or breastfeeding individuals.
- •History of cancer.
- •History of spinal cord lesions including malignant, demyelinating, or inflammatory.
- •History of prior spinal surgery.
- •History of implantable devices.
- •History of MR claustrophobia.
- •Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
- •Scoliosis.
- •Patients with LMD:
- •Age < 18 years
- •History of spinal cord lesions including malignant, demyelinating, or inflammatory.
- •History of prior spinal surgery.
- •History of implantable devices.
- •History of MR claustrophobia.
- •Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
- •Scoliosis.
研究组 & 干预措施
Patients
Participants will be recruited from DI volunteer pool to implement MRS spine on.
干预措施: Magnetic Resonance Spectroscopy (MRS) Scan (Diagnostic Test)
Healthy Volunteers
Participants will be recruited from DI volunteer pool to implement MRS spine on.
干预措施: Magnetic Resonance Spectroscopy (MRS) Scan (Diagnostic Test)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
未报告次要终点