Relapsing-remitting Multiple Sclerosis (rrMS)Phase 1NCT01738347
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).
A Phase 1 study testing Arm 1 - GEH120714 (18F) Injection in people with Relapsing-remitting Multiple Sclerosis (rrMS), run by GE Healthcare at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis (rrMS)
- What is being tested?
- Arm 1 - GEH120714 (18F) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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.
- The subject has family history of multiple sclerosis (MS).
- The subject is undergoing monitoring of occupational ionising radiation exposure.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- Arm 1 - GEH120714 (18F) Injection
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 - GEH120714 (18F) InjectionDrug
Also called GEH120714 (18F)
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - GEH120714 (18F) Injection | Experimental | Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration). Receives: Drug: Arm 1 - GEH120714 (18F) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Secondary outcomes (1)
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).
Measured: 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,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple Sclerosis (rrMS)Studies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Probe Development and Commercialization
- Responsible party
- Sponsor
- Investigators
- Paul Sherwin, M.D., Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738347
- Sponsor's protocol ID
- GE-180-001
- Status last verified
- Feb 2017
- First submitted
- 13 Nov 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01738347
- Acronym / sponsor ID
- GE-180-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Probe Development and Commercialization
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - GEH120714 (18F) Injection | Experimental | Drug: Arm 1 - GEH120714 (18F) InjectionIntervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 - GEH120714 (18F) InjectionAlso: GEH120714 (18F)Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration). | Drug | Arm 1 - GEH120714 (18F) Injection |
Primary outcome
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.
Time frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
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.
1 secondary outcome
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).
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sherwin, M.D. study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arm 1 - GEH120714 (18F) Injection in people with Relapsing-remitting Multiple Sclerosis (rrMS), run by GE Healthcare at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.