Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00928382
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-06-24
Brief Title:
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
Status:
COMPLETED
Status Verified Date:
2012-04-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 serumplasma and imaging biomarkers in healthy participants and compare these with serumplasma and imaging biomarkers values in patients with vertebral metastases with and without spinal cord compression
To detect differences in the serumplasma and imaging biomarkers in patients with vertebral metastases with and without spinal cord compressions
To correlate serumplasma 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 serumplasma biomarker evaluations
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 serumplasma and imaging biomarkers in healthy participants and compare these with serumplasma and imaging biomarkers values in patients with vertebral metastases with and without spinal cord compression
To detect differences in the serumplasma and imaging biomarkers in patients with vertebral metastases with and without spinal cord compressions
To correlate serumplasma 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 serumplasma biomarker evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 09-C-0113 | None | None | None |