Clinical trial NCT01738347: Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).
Official title: Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing-remitting Multiple Sclerosis (rrMS)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Centre for Probe Development and Commercialization
First posted: 2012-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and participants with relapsing and remitting multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for all Participants:

* The subject has a clinically normal or acceptable medical history and physical examination at screening.
* The subject has an acceptable kidney function (eGFR \>60 mL/min/1.73m2) for administration of Gadolinium.
* The subject has a trans-locator protein (TSPO) platelet assay conducted with documented results.

Inclusion Criteria for all healthy volunteers:

* The subject has no clinical history or signs of neurological impairment.
* The subject has a normal MRI without central white white matter lesions.

Inclusion Criteria specific for participants with relapsing and remitting results sclerosis (rrMS):

* Subject with a previous diagnosis of rrMS, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion on MRI.
* The subject at screening has a MRI scan of sufficient quality for Volume of Interest (VOI) definition and co-alignment with Positron Emission Tomography (PET).

Exclusion Criteria:

General Exclusion Criteria for all participants:

* The subject has a contraindication for Magnetic Resonance Imaging (MRI).
* The subject has known allergies to Gadolinium contrast agent.
* The subject has received significant ionising radiation exposure from clinical trials or medical examinations in the last 12 months.

Exclusion Criteria specific for healthy volunteers:

* The subject has family history of multiple sclerosis (MS).
* The subject is undergoing monitoring of occupational ionising radiation exposure.

Exclusion Criteria specific for participants with remitting multiple sclerosis (rrMS):

* The subject has a past history of cerebrovascular disease or vasculitis.
* The subject has a history of head injury with prolonged coma.

Primary outcomes:
measure: Recording the occurrence of adverse events (AEs) to evaluate the safety of a single dose of GEH120714 (18F) Injection in healthy volunteers (HV) and participants with rrMS.
timeFrame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Secondary outcomes:
measure: Blood samples collected multiple periods post injection; and urine samples at periods post injection to count radioactivity to determine bio-distribution, internal radiation dosimetry and Effective Dose (E) in healthy volunteers (HV).
timeFrame: Time zero equals the date of contrast imaging and up to the evaluation of the images and the kinetic modelling of cerebral uptake of GEH120714 (18F) Injection,
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph Healthcare
state: Ontario
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, M.D.
role: STUDY_DIRECTOR
References: