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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00498277 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Procedure: Magnetic Resonance Imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Quantitative Diffusion and Fat Imaging of Vertebral Fractures |
| Enrollment: | 21 |
| Study Start Date: | August 2004 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Spinal MRI |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study participants with osteoporosis that have already been scheduled for MRI exams of the spine.
Inclusion Criteria:
1. Patients with suspected vertebral compression fractures scheduled a standard of care MRI of the spine.
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jingfei Ma, PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Jingfei Ma, PhD/Associate Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00498277 History of Changes |
| Other Study ID Numbers: | 2004-0317 |
| Study First Received: | July 6, 2007 |
| Last Updated: | July 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Osteoporosis Magnetic Resonance Imaging Vertebral Fractures |
Quantitative Diffusion Fat Imaging Spine |
|
Osteoporosis Spinal Fractures Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Spinal Injuries Back Injuries Wounds and Injuries Fractures, Bone |
