Cancer Clinical Trial
Official title:
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
Verified date | April 10, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 10, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
- ELIGIBILITY CRITEREIA FOR HEALTHY PARTICIPANTS Inclusion Criteria: -Age greater than or equal to 18 years Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Brihaye J, Ectors P, Lemort M, Van Houtte P. The management of spinal epidural metastases. Adv Tech Stand Neurosurg. 1988;16:121-76. Review. — View Citation
Gabriel K, Schiff D. Metastatic spinal cord compression by solid tumors. Semin Neurol. 2004 Dec;24(4):375-83. Review. — View Citation
Marquardt 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. Epub 2004 Mar 22. — View Citation
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