Protocol Number: 09-C-0113

Title:

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

Number:

09-C-0113

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Spinal Cord

Healthy Volunteer

Metastasis

Samples

Recruitment Keyword(s):

Spinal Cord

Spinal Cord vertebrae

Cancer

Healthy Volunteer

HV

Condition(s):

Cancer

Spine Metastasis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Gabriel K, Schiff D. Metastatic spinal cord compression by solid tumors. Semin Neurol. 2004 Dec;24(4):375-83.

Brihaye J, Ectors P, Lemort M, Van Houtte P. The management of spinal epidural metastases. Adv Tech Stand Neurosurg. 1988;16:121-76.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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