NCT00928382已完成不适用
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
One of the complications of having cancer in the spinal vertebrae is that it can spread and lead to compression of the spinal cord. Spinal cord compression is a serious event that needs to be treated quickly in order to prevent permanent damage to the spinal cord and nerves.
- Researchers currently do not have the ability to accurately predict whether cancer of the vertebrae will cause spinal cord compression. It is possible that accurate predictions could allow doctors to treat patients even before they develop symptoms of spinal cord compression, thereby preventing some of the long-term consequences.
Objectives:
- To compare patients with cancer of the spinal vertebrae with and without symptoms of spinal cord compression by looking at markers in the blood and changes on novel magnetic resonance imaging (MRI) techniques that might allow researchers to predict who will experience spinal cord compression before they actually begin to have symptoms.
Eligibility:
- One group of healthy volunteers 18 years of age and older.
- One group of patients 18 years of age and older who have cancer that has spread to the vertebrae without symptoms of spinal cord compression.
- One group of patients 18 years of age and older who have cancer that has spread to the vertebrae with symptoms of spinal cord compression.
Design:
- Healthy volunteers:
- Blood will be drawn from each volunteer for initial tests and for more specific biomarker tests.
- Comprehensive MRI of the spine, followed by a special type of MRI called diffusion tensor imaging (DTI). It is believed that DTI may be even more sensitive in revealing spinal cord abnormalities than regular MRI sequences.
- Patients with cancer of the vertebrae:
- Researchers will obtain information such as pathology reports, laboratory results, diagnosis and treatment history, physical exam (PE) information, results of scans such as x-rays, MRI, computerized tomography (CT), and positron emission tomography (PET), and planned treatment details.
- Additional blood samples will be taken for specific biomarker tests.
- Questionnaire about pain, unusual sensations or numbness, bladder or bowel problems, and mobility.
- Comprehensive MRI of the spine, followed by a DTI.
- Patients who appear to have symptoms of spinal cord compression will be offered standard radiation treatment.
详细描述
Background:
- Metastatic Epidural Spinal Cord Compression (MESCC) is an acute and common complication with grave prognosis.
- Biomarkers for early detection and prediction of outcome in these patients may allow a more objective treatment decision algorithm and hopefully change the unfortunate outcome described.
- Serum S-100b, NSE and GFAP and Plasma NF-H are surrogates for neuronal damage in humans and animal models.
- Diffusion tensor imaging (DTI) has been used in brain disorders, in predicting Spinal Cord Injury outcome in animal models, and was found to be beneficial in detecting spinal cord abnormalities in human subjects with acute and slowly progressive cord compression.
Objectives:
- To compare and evaluate the feasibility and reproducibility of DTI of the spinal cord in healthy participants, to optimize the DTI Images and determine normal spine DTI values,
- To describe normal variations of serum/plasma and imaging biomarkers in healthy participants and compare these with serum/plasma and imaging biomarkers values in patients with vertebral metastases with and without spinal cord compression.
- To detect differences in the serum/plasma and imaging biomarkers in patients with vertebral metastases with and without spinal cord compressions.
- To correlate serum/plasma and imaging biomarkers differences with clinical outcomes of patients with vertebral metastases with spinal cord compression (pain, ambulation, continence and survival at 1, 3, 6 and 12 months from radiotherapy).
Eligibility:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
排除标准
- •Inability to provide informed consent.
- •History or concomitant central nervous system injury or inflammatory disease (such as stroke, trauma or multiple sclerosis).
- •History of radiation therapy to CNS.
- •History of brain or spinal cord surgical procedure.
- •Contraindication for MR scanning:
- •cardiac pacemaker
- •metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their skull
- •severe claustrophobia
- •metallic orthopedic or other implants
- •Allergy to MRI contrast agent.
- •Compromised renal function (serum creatinine greater than 1.5) unless patient is on dialysis.
- •ELIGIBILITY CRITERIA FOR PATIENT PARTICIPANTS
- •Inclusion Criteria:
- •Age greater than or equal to 18 years
- •Histologically confirmed cancer.
- •Metastatic lesions in the spinal vertebrae, confirmed by CT/MRI/Bone Scan.
- •An ECOG performance status of 0, 1 or 2
- •A life expectancy of greater than 3 months
- •The patient has been evaluated by a neurosurgeon and is not considered a candidate for surgery
- •The patient must have a primary physician who specializes in oncology and is willing to collaborate with the ROB staff in the clinical management of the patient.
- •Exclusion Criteria:
- •Inability to provide informed consent
- •Patients with primary or secondary CNS malignancy.
- •History of spinal cord compression.
- •History or concomitant central nervous system injury or inflammatory disease (such as stroke, trauma or multiple sclerosis).
- •History of radiation therapy to CNS.
- •History or planned brain or spinal cord surgical procedure. Cancer chemotherapy, immunotherapy, or investigational agents received during the 7 days prior to study procedures (hormonal therapy is allowed).
- •Contraindication for MR scanning:
- •cardiac pacemaker
- •metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain.
- •severe claustrophobia
- •metallic orthopedic or other metal implants
- •History of allergy to MRI contrast agent.
- •Compromised renal function (serum creatinine greater than 1.5) unless patient is on dialysis.
- •Inability to return for follow up visits.
研究者
研究点 (1)
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