NCT01951300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

September 3, 2013

Last Update Submit

November 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Whole-body distribution of Gallium-68 citrate

    4 hours

Secondary Outcomes (1)

  • Absorbed dose

    4 hours

Study Arms (1)

Gallium-68 citrate

OTHER

Intravenous bolus injection of 200 MBq of Gallium-68 citrate

Other: Gallium-68 citrate

Interventions

Gallium-68 citrateOTHER

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

Gallium-68 citrate

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy 18-100 year-old men

You may not qualify if:

  • ongoing infection/inflammation proven by blood or other tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital/Turku PET Centre

Turku, FI-20521, Finland

Location

MeSH Terms

Interventions

gallium citrate

Study Officials

  • Anne Roivainen

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 26, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

FI(1)