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Completed

NCT Number: NCT01951300

68Ga-Citrate PET of Healthy Volunteers

This study investigates whole-body distribution kinetics of intravenously administered Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT). Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital/Turku PET Centre

Turku, FI-20521, Finland

About this study

Six healthy male volunteers are recruited in this study. Gallium-68 citrate radiopharmaceutical is intravenously injected as a bolus and whole-body distribution kinetics are studied by dynamic whole-body positron emission tomography/computed tomography. During imaging, serial venous blood samples are drawn, plasma is separated and radioactivity is measured by gamma counter. Immediately after imaging session, urine is voided and radioactivity is measured by gamma counting. As a final point, radiation dosimetry due to single Gallium-68 citrate injection is determined.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy 18-100 year-old men

Exclusion criteria

  • ongoing infection/inflammation proven by blood or other tests

Treatment and study plan

Gallium-68 citrate

Other

Single intravenous bolus injection of 200 MBq of Gallium-68 citrate radiopharmaceutical

Primary outcomes

  1. Whole-body distribution of Gallium-68 citrate

    Time frame: 4 hours

Secondary outcomes

  1. Absorbed dose

    Time frame: 4 hours

    Absorbed ionisation radiation dose in critical organs due to intravenous bolus injection of 200 MBq of Gallium citrate

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

68Ga-Citrate Positron Emission Tomography (PET) of Healthy Volunteers

Acronym: SITRAT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Nov 4, 2015

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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