Clinical Trials Directory

Trials / Completed

CompletedNCT01049087

Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Zealand University Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The purpose of the present study is to compare plasma volume determination by 99mTc-labeled albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that plasma volume determined by the different methods are the same.

Detailed description

For many years, radioiodinated albumin has been "the golden standard" for measurement of plasma volume. There are a number of clinical situations in which a nuclide with a shorter half-life would be preferred. Furthermore, due to periodic lapses in the availability in the delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for plasma volume determination. 99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high labeling efficiency and short half-life. In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume is estimated from multiple postinjection samples for accurate zero-time extrapolation in order to correct for leakage of labeled albumin from the vascular compartment.

Conditions

Interventions

TypeNameDescription
RADIATIONPlasma volume determination (99mTc-albumin)The test is performed using 5MBq technetium-labeled albumin (99mTc-albumin-Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
RADIATIONPlasma volume determination (125I-albumin)The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.

Timeline

Start date
2012-01-01
Primary completion
2012-01-01
Completion
2012-12-01
First posted
2010-01-14
Last updated
2013-03-20

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01049087. Inclusion in this directory is not an endorsement.