NCT00928382

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

Completed Last updated 2 July 2017

What this trial tests

trial in Cancer in 30 participants. Completed in 10 April 2012.

Timeline

31 March 2009

10 April 2012

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	31 March 2009
Estimated completion	10 April 2012
Sites	1 location across United States

Conditions studied

• Cancer — all drugs for Cancer →
• Spine Metastasis — all drugs for Spine Metastasis →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 90, any sex, with Cancer or Spine Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.