Evaluation of Radiation Dose for [11C]Cimbi-36
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Effective dose and absorbed dose for selected organs
Study Overview
Brief Summary
The purpose of this study is to determine the dosimetry for the Positron Emission Tomography (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11 labelling position.
Detailed Description
Healthy subjects wil undergo a whole-body Positron Emission Tomography (PET) scan with the Serotonin 2A Receptor (5-HT2A) radioligand [11C]Cimbi-36 or [11C]Cimbi-36-5 to determine the effective radiation dose and radiation dose for selected organs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years of age
- •Signed informed consent
Exclusion Criteria
- •Present or former neurological disease, severe somatic or psychiatric disease, or medication thet can interfere with the test results.
- •Pregnancy at the time of the scan
- •Breastfeeding
- •Alcohol or substance abuse
- •Exposure to radiation (>10 millisievert (mSv)) within the last year, or significant exposure at work
- •Allergy to any of the substances in the Investigational medicinal product (IMP) formulation
Arms & Interventions
[11C]Cimbi-36
[11C]Cimbi-36
Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
Intervention: [11C]Cimbi-36 (Drug)
[11C]Cimbi-36-5
[11C]Cimbi-36-5
Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
Intervention: [11C]Cimbi-36-5 (Drug)
Outcomes
Primary Outcomes
Effective dose and absorbed dose for selected organs
Time Frame: 0 - 120 minutes
Based on the Positron Emission Tomography (PET) scan Time activity curves (TACs) will be generated and used for calculating the radiation doses for selected organs and over all effective radiation dose.
Secondary Outcomes
- Measurement of radioactive metabolites in plasma(0 - 120 minutes)
- Measurement of radioactivity in plasma and whole blood(0 - 120 minutes)
Investigators
Gitte Moos Knudsen
Chair, Professor, MD, DMSc
Rigshospitalet, Denmark