68Ga-Citrate PET of Healthy Volunteers

NCT ID: NCT01951300

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gallium-68 citrate

Intravenous bolus injection of 200 MBq of Gallium-68 citrate

Group Type OTHER

Gallium-68 citrate

Intervention Type OTHER

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

Interventions

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Gallium-68 citrate

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy 18-100 year-old men

Exclusion Criteria

* ongoing infection/inflammation proven by blood or other tests
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anne Roivainen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Roivainen

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital/Turku PET Centre

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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167/2013

Identifier Type: -

Identifier Source: org_study_id

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