HealthyPhase 1NCT02629003
[11C]Cimbi-36 Dosimetry
A Phase 1 study testing [11C]Cimbi-36 and [11C]Cimbi-36-5 in people with Healthy, run by Gitte Moos Knudsen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [11C]Cimbi-36 and [11C]Cimbi-36-5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to 10 Oct 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Radiation Dose for [11C]Cimbi-36
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- [11C]Cimbi-36, [11C]Cimbi-36-5
- Keywords
- Positron Emission Tomography, Serotonin, 5-HT2A, Radioligand, Radiation dosimetry, Radiation dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]Cimbi-36Drug
[11C]Cimbi-36-5Drug
| Study group | Role | What they receive |
|---|---|---|
| [11C]Cimbi-36 | Active comparator | [11C]Cimbi-36
Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) Receives: Drug: [11C]Cimbi-36 |
| [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.) Receives: Drug: [11C]Cimbi-36-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 - 120 minutes
Secondary outcomes (2)
Measurement of radioactive metabolites in plasma
Venous blood samples will be used to measure radioactive metabolites and parent compound in the blood, using radio-High-performance liquid chromatography (HPLC). The parameters will be parent radioactivity and metabolite radioactivity as a fraction (unitless) of total radioactivity in plasma over time (unit = minutes).
Measured: 0 - 120 minutes
Measurement of radioactivity in plasma and whole blood
Venous blood samples will be used to measure radioactivity in plasma and whole blood. The measurement will be given as a ratio (unitless) of plasma radioactivity relative to whole blood radioactivity over time (unit = minutes).
Measured: 0 - 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gitte Moos Knudsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gitte Moos Knudsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gitte M Knudsen, MD, DMSc, Study chair, Neurobiology Research Unit, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629003
- Sponsor's protocol ID
- H-15001910
- Status last verified
- Mar 2019
- First submitted
- 7 Dec 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiation Dose for [11C]Cimbi-36
- ClinicalTrials.gov ID
- NCT02629003
- Acronym / sponsor ID
- H-15001910
- Conditions
- Healthy
- Keywords
- Positron Emission Tomography, Serotonin, 5-HT2A, Radioligand, Radiation dosimetry, Radiation dosage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Gitte Moos KnudsenUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 11 Dec 2015 (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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [11C]Cimbi-36 | Active comparator | Drug: [11C]Cimbi-36[11C]Cimbi-36 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) |
| [11C]Cimbi-36-5 | Active comparator | Drug: [11C]Cimbi-36-5[11C]Cimbi-36-5 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Signed informed consent
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| [11C]Cimbi-36 | Drug | [11C]Cimbi-36 |
| [11C]Cimbi-36-5 | Drug | [11C]Cimbi-36-5 |
Primary outcome
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.
2 secondary outcomes
Measurement of radioactive metabolites in plasma
Time frame: 0 - 120 minutes
Measurement of radioactivity in plasma and whole blood
Time frame: 0 - 120 minutes
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 26 Mar 2019.
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
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.
Gitte M Knudsen, MD, DMSc study chair
Neurobiology Research Unit, Rigshospitalet
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 [11C]Cimbi-36 and [11C]Cimbi-36-5 in people with Healthy, run by Gitte Moos Knudsen at 1 site in Denmark.
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 2 inclusion and 6 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 26 Mar 2019. 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 Denmark. 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?
Effective dose and absorbed dose for selected organs (time frame: 0 - 120 minutes). 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 26 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.