Back to resultsAssess 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).
Primary Purpose
Relapsing-remitting Multiple Sclerosis (rrMS)
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Arm 1 - GEH120714 (18F) Injection
Sponsored by
About this trial
This is an interventional other trial for Relapsing-remitting Multiple Sclerosis (rrMS)
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.
Sites / Locations
- St. Joseph Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1 - GEH120714 (18F) Injection
Arm Description
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Outcomes
Primary Outcome Measures
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.
Record 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.
Secondary Outcome Measures
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).
Collect blood samples at multiple time periods up to 120 minutes post drug injection; and urine samples at multiple time periods up to 270 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) per protocol in healthy volunteers (HV).
Full Information
NCT ID
NCT01738347
First Posted
November 13, 2012
Last Updated
February 23, 2017
Sponsor
GE Healthcare
Collaborators
Centre for Probe Development and Commercialization
1. Study Identification
Unique Protocol Identification Number
NCT01738347
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
Centre for Probe Development and Commercialization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis (rrMS)
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - GEH120714 (18F) Injection
Arm Type
Experimental
Arm Description
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Intervention Type
Drug
Intervention Name(s)
Arm 1 - GEH120714 (18F) Injection
Other Intervention Name(s)
GEH120714 (18F)
Intervention Description
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Primary Outcome Measure Information:
Title
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.
Description
Record 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.
Time Frame
Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Secondary Outcome Measure Information:
Title
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).
Description
Collect blood samples at multiple time periods up to 120 minutes post drug injection; and urine samples at multiple time periods up to 270 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) per protocol in healthy volunteers (HV).
Time Frame
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,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sherwin, M.D.
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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).
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