Last updated: 11/03/2018 17:44:48
[18F]PBR111 and microglial activation in Multiple Sclerosis
GSK study ID
115241
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: A study to characterize the novel TSPO PET radioligand [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis
Trial description: This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
VT of [18F]PBR111
Timeframe: day 30
Secondary outcomes:
Test-retest variability of regional [18F]PBR111
Timeframe: 8 months
regional [18F]PBR111 VT
Timeframe: 1.5 years
White matter lesion load and distribution
Timeframe: 1.5 years
Cortical grey matter lesion load and distribution
Timeframe: 1.5 years
Genetic polymorphisms related to the TSPO gene
Timeframe: 1.5 years
Interventions:
Radiation: [18F]PBR111
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2011 to March 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
20 - 70 years
Accepts healthy volunteers
Yes
- 1. Male or Female, aged 20-70
- 2. Able to read, comprehend and record information written in English.
- 1. If female, positive urine pregnancy test
- 2. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2
Inclusion and 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. -
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, W12 0NN
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2013-28-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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