68Ga-Citrate PET of Healthy Volunteers (SITRAT)

November 3, 2015 updated by: Anne Roivainen, Turku University Hospital

68Ga-Citrate Positron Emission Tomography (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FI-20521
        • Turku University Hospital/Turku PET Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy 18-100 year-old men

Exclusion Criteria:

  • ongoing infection/inflammation proven by blood or other tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whole-body distribution of Gallium-68 citrate
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorbed dose
Time Frame: 4 hours
Absorbed ionisation radiation dose in critical organs due to intravenous bolus injection of 200 MBq of Gallium citrate
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Anne Roivainen, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 167/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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