Status:
COMPLETED
A Pilot Study to Explore Serum and Imaging Biomarkers in Patients With Spinal Cord Compression
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cancer
Spine Metastasis
Eligibility:
All Genders
18-90 years
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 ...
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 patient...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITEREIA FOR HEALTHY PARTICIPANTS
- Age greater than or equal to 18 years
Exclusion
- 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.
Key Trial Info
Start Date :
March 31 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 10 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00928382
Start Date
March 31 2009
End Date
April 10 2012
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892