Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001762
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
1999-11-03
Brief Title:
Magnetic Resonance Imaging of the Face and Bones
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Magnetic Resonance Imaging to Study Avascular Necrosis in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2013-07-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-I-0070 | None | None | None |