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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01049087
Enrollment
15
Registered
2010-01-14
Start date
2012-01-31
Completion date
2012-12-31
Last updated
2013-03-20

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

Conditions

Healthy

Keywords

plasma volume, technetium-labeled albumin, radioiodine-labeled albumin, Healthy volunteers

Brief 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.

Interventions

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.

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI \< 27 kg/m2 * Written informed consent

Exclusion criteria

* Hypertension (140/90 mmHg) * Diabetes mellitus * Any use of medication * Pregnancy

Design outcomes

Primary

MeasureTime frame
Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albuminJanuary 2011

Secondary

MeasureTime frame
Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulationJanuary 2011

Countries

Denmark

Outcome results

None listed

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