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


N/A
18 Years
90 Years
Not Enrolling
Both
Cancer, Spine Metastasis

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Trial Information

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


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.


- 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Susan E Bates, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

090113

NCT ID:

NCT00928382

Start Date:

March 2009

Completion Date:

April 2012

Related Keywords:

  • Cancer
  • Spine Metastasis
  • Spinal Cord
  • Healthy Volunteer
  • Metastasis
  • Samples
  • Spinal Cord Vertebrae
  • Cancer
  • HV
  • Neoplasm Metastasis
  • Spinal Cord Compression

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892