Trial Information

A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression

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.