Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

Beth Israel Lahey Health

Status: Completed

Conditions: Progressive Multifocal Leukoencephalopathy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01132053

NS 047029 (Other Grant/Funding Number)

2004P000089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 2 patient groups

PML

Description:

These are subjects who have confirmed PML.

Control

Description:

These are subjects who do not have PML. They may be healthy or immune compromised due to Cancer, Transplant, or HIV.