Quantitative Diffusion and Fat Imaging of the Spine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00498277
First received: July 6, 2007
Last updated: July 31, 2012
Last verified: July 2012

July 6, 2007
July 31, 2012
August 2004
July 2009   (final data collection date for primary outcome measure)
MRIs of diffusion (the random motion of molecules) and fat [ Time Frame: One extra 10 minute MRI sequence during scheduled spine exam. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00498277 on ClinicalTrials.gov Archive Site
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Quantitative Diffusion and Fat Imaging of the Spine
Quantitative Diffusion and Fat Imaging of Vertebral Fractures

Primary Objective:

The purpose of this study is to determine whether or not combined quantitative diffusion and fat MR imaging techniques can differentiate between benign and malignant vertebral fractures.

Researchers believe that they may be able to use MRI scans to tell if fractures of the bones in the spine are due to cancer. They believe this can be done by looking at MRIs of diffusion (the random motion of molecules) and fat. For benign and malignant processes, either diffusion or fat, or both of them, can be different, because the cell density (which affects diffusion) and bone marrow content (which affects fat) are expected to be different.

All patients in this study will have already been scheduled for MRI exams of the spine at UTMDACC.

You will have one extra MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion. The extra time required for the study should be less than 10 minutes, and the total imaging time should fall within a standard MRI time slot.

Available data from your medical record, including imaging data, will be used to set up guidelines and clear examples for checking spinal fractures.

This is an investigational study. A total of 48 patients will take part in the study. All will be enrolled at UTMDACC.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Study participants with osteoporosis that have already been scheduled for MRI exams of the spine.

Osteoporosis
Procedure: Magnetic Resonance Imaging
One MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion.
Other Name: MRI
Spinal MRI
Intervention: Procedure: Magnetic Resonance Imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. Patients with suspected vertebral compression fractures scheduled a standard of care MRI of the spine.

Exclusion Criteria:

  1. Patients who are contraindicated for MRI (such as due to metal implants, cardiac pacemaker).
  2. Patients who are unable to give informed consent
  3. Patients who are younger than 18 years of age since the disease (osteoporosis) is not present in children.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498277
2004-0317
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Jingfei Ma, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP