Clareo Health | 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).
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).
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GE Healthcare
With
Centre for Probe Development and Commercialization
Age
20–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
The subject has no clinical history or signs of neurological impairment.
The subject has a normal MRI without central white white matter lesions.
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).
You may not be if
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.
The subject has family history of multiple sclerosis (MS).
The subject is undergoing monitoring of occupational ionising radiation exposure.
The subject has a past history of cerebrovascular disease or vasculitis.
The subject has a history of head injury with prolonged coma.
