Magnetic Resonance Imaging of the Face and Bones
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||May 1, 2013|
|Start Date ICMJE||February 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001762 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Magnetic Resonance Imaging of the Face and Bones|
|Official Title ICMJE||Magnetic Resonance Imaging to Study Avascular Necrosis in HIV-Infected Subjects|
This study will examine risk factors for facial wasting and avascular necrosis (AVN, a type of damage to the hip and other bones) in HIV-infected patients. The prevalence and natural history of AVN are also being evaluated. This study will use magnetic resonance imaging (MRI) to identify and monitor these conditions in patients with and without diagnosed AVN and to identify risk factors.
HIV-infected patients 18 years of age and older may be eligible for this study. HIV-infected children 4 years and older who can tolerate magnetic resonance imaging without sedation may also participate. Candidates may be screened for participation with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram. Volunteers will provide a medical history and may have a brief physical examination. The study is currently closed to normal volunteers.
HIV-infected patients will have a MRI scan of the hip bone, and possibly other bones. Before the scan, they will provide a medical history by interview or questionnaire and have a physical examination. Those with diagnosed AVN will also have blood drawn to help identify potential risk factors for AVN. For the MRI, the patient lies flat on a stretcher that is moved into a cylindrical machine with a strong magnetic field. Earplugs are worn to muffle thumping sounds produced by radio waves that form the images. Patients can speak with a staff member via an intercom system at all times during the procedure. Repeat MRI studies will be requested at approximately 3- to 12-month intervals for up to 5 years, to see if changes occur with time. If medically indicated, additional diagnostic studies may be done to obtain information needed for appropriate medical care. Blood will be drawn periodically to examine immune parameters and viral blood levels. Patients with AVN may have periodic consultations with the rehabilitation medicine service and orthopedic surgeons.
In this minimal risk protocol, up to 400 asymptomatic HIV-infected patients and 75 HIV-infected patients with AVN will have MRI scans of the hips in order to determine (1) if avascular necrosis (AVN) of the hip can be identified by MRI scans in HIV-infected patients, and (2) to follow the natural history of asymptomatic and symptomatic AVN of the hip. Study procedures include MRI of the hip, a minimal risk imaging study, and phlebotomy.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||675|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Adult patients (18 and older) who are thought likely to tolerate the MRI without sedation.
Willing and able to provide written informed consent.
No contraindication to MRI as below:
For hip MRI of patients with known AVN: known HIV infection, based on patient history or NIH or referring physician records, and AVN previously diagnosed by X-ray or MRI scans.
Prior intolerance of head MRI (noise, claustrophobia, etc).
Pregnancy (fertile women must have a negative pregnancy test to within 2 weeks of the MRI and must be using a reliable method of birth control).
Presence of specific contraindication for MRI:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001762|
|Other Study ID Numbers ICMJE||980070, 98-I-0070|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2012|
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