[18F]PBR111 and Microglial Activation in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01428505
• Date of registration: 01/09/2011
• Primary sponsor: GlaxoSmithKline
• Public title: [18F]PBR111 and Microglial Activation in Multiple Sclerosis
• Scientific title: A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis
• Date of first enrolment: July 2011
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01428505
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective

Countries of recruitment

United Kingdom

Contacts

• Name: US GSK Clinical Call Center

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or Female, aged 20-70

2. Able to read, comprehend and record information written in English.

3. Capable of giving written informed consent

4. Provide a venous blood sample that will be used for genetics research and the in
vitro ligand binding assay.

5. A female subject is eligible to participate if she is willing to follow contraception
guidelines or if she is of non-childbearing potential.

6. Male subjects must agree to use one of the contraception methods

MS subjects:

1. Clinical or clinical and laboratory supported diagnosis of multiple sclerosis

2. EDSS score up to and including 7.5 at screening evaluation

Healthy Volunteers:

1. Healthy control subjects defined as free from clinically significant active disease as
assessed by the Principal Investigator from their medical and psychiatric past and present
history

-

Exclusion Criteria:

1. If female, positive urine pregnancy test

2. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2

3. History or presence of a neurological diagnosis

4. Previous inclusion in a research and/or medical protocol involving nuclear medicine,
PET or radiological investigations with radiation exposure.

5. Family history of cancer (one or more first-degree relative diagnosed before the age
of 55).

6. Subject or caregiver is an immediate family member or employee of the participating
Investigator, any of the participating site staff or GSK staff.

7. Any subject the investigator deems unsuitable for the study (e.g., due to either
medical reasons, laboratory abnormalities or subject's unwillingness to comply with
all study-related procedures).

8. Contraindications to MRI scanning

9. Any physical abnormality or functional disability which prevents the subject from
acquiring a suitable position for scanning.

10. History of or suffers from claustrophobia or feels that he will be unable to lie
still on his back in the PET camera or MRI scanner for a period of at least 90mins.

11. Unwillingness or inability to follow the procedures outlined in the protocol. -



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Radiation: [18F]PBR111

Primary Outcome(s)

VT of [18F]PBR111 [Time Frame: day 30]

Secondary Outcome(s)

Cortical grey matter lesion load and distribution [Time Frame: 1.5 years]

Genetic polymorphisms related to the TSPO gene [Time Frame: 1.5 years]

regional [18F]PBR111 VT [Time Frame: 1.5 years]

Test-retest variability of regional [18F]PBR111 [Time Frame: 8 months]

White matter lesion load and distribution [Time Frame: 1.5 years]

Secondary ID(s)

115241

Source(s) of Monetary Support

Please refer to primary and secondary sponsors