Quantitative Diffusion and Fat Imaging of the Spine

Osteoporosis Clinical Trial

Official title:

Quantitative Diffusion and Fat Imaging of Vertebral Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498277
• Other study ID #: 2004-0317
• Status: Completed
• Phase: N/A
• First received: July 6, 2007
• Last updated: July 31, 2012
• Start date: August 2004
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRIs of diffusion (the random motion of molecules) and fat		One extra 10 minute MRI sequence during scheduled spine exam.	No

External Links

•   UT MD Anderson Cancer Center