NCT00498277

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

4.9 years

First QC Date

July 6, 2007

Last Update Submit

July 31, 2012

Conditions

Osteoporosis

Keywords

OsteoporosisMagnetic Resonance ImagingVertebral FracturesQuantitative DiffusionFat ImagingSpine

Outcome Measures

Primary Outcomes (1)

  • MRIs of diffusion (the random motion of molecules) and fat

    One extra 10 minute MRI sequence during scheduled spine exam.

Study Arms (1)

Spinal MRI

Procedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingPROCEDURE

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

Also known as: MRI
Spinal MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

OsteoporosisSpinal Fractures

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jingfei Ma, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 10, 2007

Study Start

August 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)