Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

NCT ID: NCT01132053

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Progressive Multifocal Leukoencephalopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PML

These are subjects who have confirmed PML.

No interventions assigned to this group

Control

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chen Sabrina Tan

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen S Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NS 047029

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2004P000089

Identifier Type: -

Identifier Source: org_study_id

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