[11C]Cimbi-36 Dosimetry
Evaluation of Radiation Dose for [11C]Cimbi-36
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Dec 2015
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2018
CompletedMarch 26, 2019
March 1, 2019
2.9 years
December 7, 2015
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective dose and absorbed dose for selected organs
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.
0 - 120 minutes
Secondary Outcomes (2)
Measurement of radioactive metabolites in plasma
0 - 120 minutes
Measurement of radioactivity in plasma and whole blood
0 - 120 minutes
Study Arms (2)
[11C]Cimbi-36
ACTIVE COMPARATOR\[11C\]Cimbi-36 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
[11C]Cimbi-36-5
ACTIVE COMPARATOR\[11C\]Cimbi-36-5 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurobiology Research Unit, Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Gitte M Knudsen, MD, DMSc
Neurobiology Research Unit, Rigshospitalet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair, Professor, MD, DMSc
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 11, 2015
Study Start
December 1, 2015
Primary Completion
October 10, 2018
Study Completion
October 10, 2018
Last Updated
March 26, 2019
Record last verified: 2019-03