Quantitative Diffusion and Fat Imaging of the Spine

July 31, 2012 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRIs of diffusion (the random motion of molecules) and fat
Time Frame: One extra 10 minute MRI sequence during scheduled spine exam.
One extra 10 minute MRI sequence during scheduled spine exam.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Jingfei Ma, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 9, 2007

First Posted (Estimate)

July 10, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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