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

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ClinicalTrials.gov Identifier: NCT01049087
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : March 20, 2013
Sponsor:
Information provided by:
Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Radiation: Plasma volume determination (99mTc-albumin) Radiation: Plasma volume determination (125I-albumin) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Intervention Details:
    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.


Primary Outcome Measures :
  1. Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin [ Time Frame: January 2011 ]

Secondary Outcome Measures :
  1. Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation [ Time Frame: January 2011 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 27 kg/m2
  • Written informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049087


Locations
Denmark
University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine
Koge, Denmark, DK-4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
Study Chair: Steen Levin, MD, DMSc Zealand University Hospital
Principal Investigator: Peter K Bonfils, MD Zealand University Hospital
Study Director: Knud H Stokholm, MD Zealand University Hospital

Responsible Party: Peter Kramshoj Bonfils, University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine
ClinicalTrials.gov Identifier: NCT01049087     History of Changes
Other Study ID Numbers: SJ-112
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: January 2010

Keywords provided by Zealand University Hospital:
plasma volume
technetium-labeled albumin
radioiodine-labeled albumin
Healthy volunteers