CancerNCT00928382
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
An observational study of Cancer and Spine Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Spine Metastasis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2009to 10 Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Age greater than or equal to 18 years
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cancer, Spine Metastasis
- Keywords
- Spinal Cord, Healthy Volunteer, Metastasis, Samples, Spinal Cord Vertebrae, Cancer, HV
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study start31 Mar 2009
- Study completion10 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan E Bates, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928382
- Sponsor's protocol ID
- 090113
- Other IDs
- 09-C-0113
- Status last verified
- 10 Apr 2012
- First submitted
- 24 Jun 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gabriel K, Schiff D. Metastatic spinal cord compression by solid tumors. Semin Neurol. 2004 Dec;24(4):375-83. doi: 10.1055/s-2004-861532.
PubMed 15637649Brihaye J, Ectors P, Lemort M, Van Houtte P. The management of spinal epidural metastases. Adv Tech Stand Neurosurg. 1988;16:121-76. doi: 10.1007/978-3-7091-6954-4_4. No abstract available.
PubMed 3064753Marquardt G, Setzer M, Seifert V. Protein S-100b as serum marker for prediction of functional outcome in metastatic spinal cord compression. Acta Neurochir (Wien). 2004 May;146(5):449-52. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.
PubMed 15118880
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT00928382
- Acronym / sponsor ID
- 090113
- Conditions
- Cancer, Spine Metastasis
- Keywords
- Spinal Cord, Healthy Volunteer, Metastasis, Samples, Spinal Cord Vertebrae, Cancer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 31 Mar 2009
- Study completion
- 10 Apr 2012
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -Age greater than or equal to 18 years
- 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
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15637649Gabriel K, Schiff D. Metastatic spinal cord compression by solid tumors. Semin Neurol. 2004 Dec;24(4):375-83. doi: 10.1055/s-2004-861532.
- Background: PubMed 3064753Brihaye J, Ectors P, Lemort M, Van Houtte P. The management of spinal epidural metastases. Adv Tech Stand Neurosurg. 1988;16:121-76. doi: 10.1007/978-3-7091-6954-4_4. No abstract available.
- Background: PubMed 15118880Marquardt G, Setzer M, Seifert V. Protein S-100b as serum marker for prediction of functional outcome in metastatic spinal cord compression. Acta Neurochir (Wien). 2004 May;146(5):449-52. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Bates, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Spine Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.