Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)
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Purpose
This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.
| Condition |
|---|
|
Progressive Multifocal Leukoencephalopathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Role of Inflammation in PML |
Blood, Urine, CSF if needed for clinical management.
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | September 2013 |
| Groups/Cohorts |
|---|
|
PML
These are subjects who have confirmed PML.
|
|
Control
These are subjects who do not have PML. They may be healthy or immune compromised due to Cancer, Transplant, or HIV.
|
Detailed Description:
To determine precisely what are the host or viral factors that may predict a favorable outcome for PML patients and the role of inflammation in preventing JCV from causing brain disease. One of the goals of this study is to help establish non-invasive markers of PML evolution by studying the brain metabolism in PML lesions using Magnetic Resonance Imaging (MRI), Magnetic Spectroscopy (MRS) and other advanced imaging modalities.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
PML patients of 18 years of age or older in the Boston area will be included in this study.
The control groups will include HIV+ and HIV- individuals who need to have a lumbar puncture for their clinical management.
Inclusion Criteria:
- PML patients of 18 years of age or older will be included in this study.
Exclusion Criteria:
- Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
- Presence of confounding neurological disorder such as brain neoplasm etc.
In addition patients with a contraindication to MRI examination will be excluded from study. Contraindications to the MRI examination include:
- Medically unstable or hematological, renal, or hepatic dysfunction.
- Cardiac pacemaker
- Internal clips,
- Metal implants, or external clips with 10 mm of the head.
- Metal in the eyes.
- Pregnant
- Claustrophobia
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Igor J Koralnik, MD | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Igor Koralnik MD, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01132053 History of Changes |
| Other Study ID Numbers: | 2004-P-000089, NS 047029 |
| Study First Received: | May 26, 2010 |
| Last Updated: | May 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Beth Israel Deaconess Medical Center:
|
JCV |
Additional relevant MeSH terms:
|
Leukoencephalopathy, Progressive Multifocal Leukoencephalopathies Inflammation Pathologic Processes Encephalitis, Viral Encephalitis Central Nervous System Viral Diseases Virus Diseases |
Polyomavirus Infections DNA Virus Infections Slow Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Demyelinating Diseases |
ClinicalTrials.gov processed this record on May 23, 2013