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:

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.

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):

None

Condition(s):

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): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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