A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
Condition: Cancer; Spine Metastasis
MeSH terms: Neoplasm Metastasis; Spinal Cord Compression
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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:

        -  Healthy volunteers with no prior history or concomitant central nervous system injury or
           inflammatory disease, prior or planned brain or spinal cord radiation therapy or
           surgical procedure and with no contraindication for MR scanning.

        -  Patients with metastatic cancer in the spinal vertebrae, with or without spinal cord
           compression and with no prior history or concomitant central nervous system injury or
           inflammatory disease, brain metastases, prior brain or spinal cord radiation therapy or
           surgical procedure and with no contraindication for MR scanning.

      Design:

        -  Preliminary DTI studies will be conducted for healthy volunteer participants to
           determine normal spine DTI values, choose and optimize the scanning protocol, and
           evaluate the presence of artifacts and reproducibility of the DTI Images. Normal values
           and variability of serum and plasma biomarkers will be also determined.

        -  Patient participants with known vertebral bone metastases with or without spinal cord
           compression will undergo a DTI study along with the standard MRI sequences, used to
           evaluate MESCC patients. Blood samples for biomarkers will be also collected.

        -  Patients with documented MESCC, will be treated with standard radiotherapy fields, dose
           and schedule. Steroid treatment will be used as clinically indicated. All study
           procedures will be conducted prior to any therapy. Follow- up visits are planned at 1,
           3, 6, and 12 months after radiotherapy completion with history and physical, DTI and
           serum/plasma biomarker evaluations.
    

Time perspective: Prospective
Keywords: Spinal Cord; Healthy Volunteer; Metastasis; Samples; Spinal Cord Vertebrae; Cancer; HV