Quantitative Diffusion and Fat Imaging of the Spine - Full Text View

Purpose

Primary Objective:

1. 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

MedlinePlus related topics:

Cancer Fractures MRI Scans Osteoporosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Quantitative Diffusion and Fat Imaging of Vertebral Fractures

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

Primary Outcome Measures:

The goal of this clinical research study is to find out if the combination of quantitative diffusion and fat MRI techniques can tell the difference between spinal fractures that are caused by cancer and those that are not. [ Time Frame: 68 Months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	48
Study Start Date:	August 2004
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with osteoporosis that have already been scheduled for MRI exams of the spine.	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.

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. The extra scans will be provided free of charge. A total of 48 patients will take part in the study. All will be enrolled at UTMDACC.

This protocol is partially funded by a research grant from Radiological Society of North America (RSNA) Research Scholar Grant.

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

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who are contraindicated for MRI (such as due to metal implants, cardiac pacemaker).
Patients who are unable to give informed consent
Patients who are younger than 18 years of age since the disease (osteoporosis) is not present in children.

Contacts and Locations

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	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Jingfei Ma, PhD/Associate Professor )
Study ID Numbers:	2004-0317
First Received:	July 6, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00498277
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

Study placed in the following topic categories:

Musculoskeletal Diseases

Fractures, Bone

Spinal Fractures

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00498277