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68Ga-Citrate PET of Healthy Volunteers (SITRAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01951300
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : November 4, 2015
Information provided by (Responsible Party):
Anne Roivainen, Turku University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Gallium-68 citrate Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 68Ga-Citrate Positron Emission Tomography (PET) of Healthy Volunteers
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Gallium-68 citrate
Intravenous bolus injection of 200 MBq of Gallium-68 citrate
Other: Gallium-68 citrate
Single intravenous bolus injection of 200 MBq of Gallium-68 citrate radiopharmaceutical

Primary Outcome Measures :
  1. Whole-body distribution of Gallium-68 citrate [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy 18-100 year-old men

Exclusion Criteria:

  • ongoing infection/inflammation proven by blood or other tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01951300

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Turku University Hospital/Turku PET Centre
Turku, Finland, FI-20521
Sponsors and Collaborators
Turku University Hospital
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Principal Investigator: Anne Roivainen Turku University Hospital

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Responsible Party: Anne Roivainen, professor, Turku University Hospital Identifier: NCT01951300    
Other Study ID Numbers: 167/2013
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action