Magnetic Resonance Imaging of the Face and Bones

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001762
First received: November 3, 1999
Last updated: August 20, 2013
Last verified: July 2013
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Official Title: Magnetic Resonance Imaging to Study Avascular Necrosis in HIV-Infected Subjects

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 532
Study Start Date: February 1998
Estimated Study Completion Date: July 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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:

  1. current or prior employment as a welder or metalworker
  2. presence of cardiac or neural pacemaker, aneurysm clip, cochlear implant, metallic implant such as artificial cardiac valve, shrapnel, or permanent, non-removable body jewelry.
  3. Surgery within the last 6 months with the use of metal clips.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001762

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph A Kovacs, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001762     History of Changes
Other Study ID Numbers: 980070, 98-I-0070
Study First Received: November 3, 1999
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Protease Inhibitor
HIV Infection
Appearance
Subcutaneous Fat
Facial Wasting

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014