MedDataX Logo

Quantitative Diffusion and Fat Imaging of the Spine

NCT ID: NCT00498277

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoporosis Magnetic Resonance Imaging Vertebral Fractures Quantitative Diffusion Fat Imaging Spine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal MRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

One MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic Resonance Imaging

One MRI sequence done to look for relative fat, and a second extra MRI sequence done to look for the diffusion.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MRI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jingfei Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

UT MD Anderson Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-0317

Identifier Type: -

Identifier Source: org_study_id