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Completed

NCT Number: NCT02629003

[11C]Cimbi-36 Dosimetry

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neurobiology Research Unit, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]Cimbi-36

Drug

[11C]Cimbi-36-5

Drug

Primary outcomes

  1. 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

  1. Measurement of radioactive metabolites in plasma

    Time frame: 0 - 120 minutes

    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).

  2. Measurement of radioactivity in plasma and whole blood

    Time frame: 0 - 120 minutes

    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).

Sponsors and collaborators

Lead sponsor

Gitte Moos Knudsen

Other

Registry information

Official study title

Evaluation of Radiation Dose for [11C]Cimbi-36

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2015
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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