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Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01132053
Collaborator
National Institutes of Health (NIH) (NIH)
126
Enrollment
1
Location
174
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    126 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Role of Inflammation in PML
    Actual Study Start Date :
    Jun 1, 2004
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Dec 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • PML patients of 18 years of age or older will be included in this study.
      Exclusion Criteria:

      1. Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)

      2. 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:

      1. Medically unstable or hematological, renal, or hepatic dysfunction.

      2. Cardiac pacemaker

      3. Internal clips,

      4. Metal implants, or external clips with 10 mm of the head.

      5. Metal in the eyes.

      6. Pregnant

      7. Claustrophobia

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

      Sponsors and Collaborators

      • Beth Israel Deaconess Medical Center
      • National Institutes of Health (NIH)

      Investigators

      • Principal Investigator: Chen S Tan, MD, Beth Israel Deaconess Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Chen Sabrina Tan, principal investigator, Beth Israel Deaconess Medical Center
      ClinicalTrials.gov Identifier:
      NCT01132053
      Other Study ID Numbers:
      • 2004P000089
      • NS 047029
      First Posted:
      May 27, 2010
      Last Update Posted:
      Feb 27, 2019
      Last Verified:
      Feb 1, 2019
      Keywords provided by Chen Sabrina Tan, principal investigator, Beth Israel Deaconess Medical Center
      JC Virus
      Additional relevant MeSH terms:
      Leukoencephalopathy, Progressive Multifocal
      Leukoencephalopathies
      Inflammation

      Study Results

      No Results Posted as of Feb 27, 2019