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
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

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

Detailed Description:

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 Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498277

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jingfei Ma, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: 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 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Osteoporosis
Magnetic Resonance Imaging
Vertebral Fractures
Quantitative Diffusion
Fat Imaging
Spine

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014