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68Ga-Citrate PET of Healthy Volunteers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01951300
Acronym
SITRAT
Enrollment
6
Registered
2013-09-26
Start date
2013-09-30
Completion date
2015-10-31
Last updated
2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

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.

Interventions

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

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy 18-100 year-old men

Exclusion criteria

* ongoing infection/inflammation proven by blood or other tests

Design outcomes

Primary

MeasureTime frame
Whole-body distribution of Gallium-68 citrate4 hours

Secondary

MeasureTime frameDescription
Absorbed dose4 hoursAbsorbed ionisation radiation dose in critical organs due to intravenous bolus injection of 200 MBq of Gallium citrate

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026