NCT00928382

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2012

Completed
Last Updated

July 2, 2017

Status Verified

April 10, 2012

First QC Date

June 24, 2009

Last Update Submit

June 30, 2017

Conditions

CancerSpine Metastasis

Keywords

Spinal CordHealthy VolunteerMetastasisSamplesSpinal Cord VertebraeCancerHV

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years

You may not qualify if:

  • 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
  • Age greater than or equal to 18 years
  • Histologically confirmed cancer.
  • Metastatic lesions in the spinal vertebrae, confirmed by CT/MRI/Bone Scan.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 15637649BACKGROUND

  • Brihaye 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.

    PMID: 3064753BACKGROUND

  • 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. doi: 10.1007/s00701-004-0242-3. Epub 2004 Mar 22.

    PMID: 15118880BACKGROUND

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan E Bates, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

March 31, 2009

Study Completion

April 10, 2012

Last Updated

July 2, 2017

Record last verified: 2012-04-10

Locations

US(1)