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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Radiation: Plasma volume determination (99mTc-albumin)
* Radiation: Plasma volume determination (125I-albumin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 27 kg/m2 Written informed consent Exclusion Criteria: Hypertension (140/90 mmHg) Diabetes mellitus Any use of medication Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Plasma 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.|
|Radiation: Plasma 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin |  | January 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation |  | January 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma volume, technetium-labeled albumin, radioiodine-labeled albumin, Healthy volunteers