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Completed

NCT Number: NCT01049087

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine

Køge, DK-4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI < 27 kg/m2
  • Written informed consent

Exclusion criteria

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

Treatment and study plan

Plasma volume determination (99mTc-albumin)

Radiation

The test is performed using 5MBq technetium-labeled albumin (99mTc-albumin-Vasculosis) with several postinjection samples for accurate zero-time extrapolation.

Plasma volume determination (125I-albumin)

Radiation

The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.

Primary outcomes

  1. Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin

    Time frame: January 2011

Secondary outcomes

  1. Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation

    Time frame: January 2011

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2010
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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