Protocol Number: 07-N-0092

Title:

PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [(11)C]PBR28 in Patients with Multiple Sclerosis (MS)

Number:

07-N-0092

Summary:

This study will use positron emission tomography (PET) to measure a brain protein called peripheral benzodiazepine receptor (PBR) in patients with multiple sclerosis. PBR is created during the inflammation process, and brain inflammation is a key feature of multiple sclerosis (MS). PBR usually affects one type of brain cell, but it can also cause damage to surrounding areas of the brain in patients with MS. PET studies of PBRs and brain inflammation may help elucidate the role of these brain cells in patients with MS.

Healthy normal volunteers and patients with MS between 18 and 70 years of age may be eligible for this study. Patients with MS must have had onset of disease between 18 and 40 years of age.

Patients with MS undergo the following procedures:

Visit 1: Medical history, physical examination, blood tests and magnetic resonance imaging (MRI).

Visit 2: Blood tests and PET scan.

Visits 3 and 4: MRI and physical examination.

Visit 5: PET scan and blood tests.

Visit 6: MRI and physical examination.

Healthy volunteers undergo the following:

Visit 1: Medical history, physical examination, blood tests.

Visits 2 and 3: PET and blood tests.

Magnetic Resonance Imaging

MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud knocking noises that occur during the scanning process. The procedure lasts about 90 minutes; the patient is asked to lie still for up to 25 minutes at a time. The subject can communicate with the MRI staff at all times during the scan. During part of the scan a contrast agent is administered through a catheter (plastic tube) placed in an arm vein to enhance the images.

Positron Emission Tomography (PET)

The PET scan gives information on brain and body chemistry and function. The subject lies on a bed that slides in and out of the doughnut-shaped scanner. A catheter is placed in a vein in the arm and another is placed in an artery in the wrist or elbow area. The catheter in the arm is used for injecting a radioactive material that the scanner detects, and the other is used to collect blood samples. A custom-molded plastic mask is used to support the head and prevent it from moving during the procedure. The subject may be asked to perform various tasks during the PET scan or to lie quietly. The scan lasts about 2.5 hours.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

SUBJECTS WITH MULTIPLE SCLEROSIS - INCLUSION CRITERIA:

- Ages between 18 and 70, inclusive.

- Diagnosis of definite MS according to published criteria.

- The presence of at least one gadolinium-enhancing lesion on the screening brain magnetic resonance image (MRI), and T2 lesion load volume greater than 5 cc.

- Subjects must be able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.

SUBJECTS WITH MULTIPLE SCLEROSIS - EXCLUSION CRITERIA:

- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual guidelines.

- Pregnancy and breast-feeding.

- Presence of ferromagnetic metal in the body or heart pacemaker.

- ECG with clinically significant abnormalities.

- Positive HIV test.

- Positive pregnancy test.

- Concurrent medical conditions including hepatic cirrhosis, end-stage renal disease or any acute and severe decompensation of disease that in the opinion of the investigator would compromise the safety of the patient.

- Subjects with cognitive impairment who are unable to provide written, informed consent.

- Subjects who have received immunomodulatory/disease-modifying therapy, including investigational MS therapy, within 12 weeks prior to PET imaging or who have received corticosteroids within 6 weeks prior to PET imaging.

HEALTHY VOLUNTEERS - INCLUSION CRITERIA:

All subjects must be healthy and aged 18-65 years.

HEALTHY VOLUNTEERS - EXCLUSION CRITERIA:

'Non-binding' on screening whole body [(11)C]PBR28 PET scan.

Current psychiatric illness, substance abuse or severe systemic disease based on history and physical exam.

ECG with clinically significant abnormalities. Any existing physical exam and ECG within one year will be reviewed and if none already exists in the chart, these will be obtained and reviewed.

Laboratory tests with clinically significant abnormalities.

Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual guidelines.

Pregnancy and breast-feeding.

Positive pregnancy test.

Claustrophobia.

Presence of ferromagnetic metal in the body or heart pacemaker.

Positive HIV test.

A history of brain disease.

Special Instructions:

Currently Not Provided

Keywords:

Inflammation

Neuroimmunology

Recruitment Keyword(s):

Multiple Sclerosis

MS

Healthy Volunteer

HV

Condition(s):

Multiple Sclerosis

Investigational Drug(s):

[(11)C]PBR28

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7.

Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52.

Cotton F, Weiner HL, Jolesz FA, Guttmann CR. MRI contrast uptake in new lesions in relapsing-remitting MS followed at weekly intervals. Neurology. 2003 Feb 25;60(4):640-6.

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