Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

Progressive Multifocal Leukoencephalopathy Clinical Trial

Official title:

Role of Inflammation in PML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132053
• Other study ID #: 2004P000089
• Secondary ID: NS 047029
• Status: Completed
• Start date: June 2004
• Est. completion date: December 2018

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Leukoencephalopathies
• Leukoencephalopathy, Progressive Multifocal
• Progressive Multifocal Leukoencephalopathy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,