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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01049087
First Posted: January 14, 2010
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Koge
Information provided by:
Zealand University Hospital
  Purpose
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 Intervention
Healthy Radiation: Plasma volume determination (99mTc-albumin) Radiation: Plasma volume determination (125I-albumin)

Study Type: Interventional
Study Design: 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

Further study details as provided by Zealand University Hospital:

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

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

Enrollment: 15
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
University Hospital Koge
Investigators
Study Chair: Steen Levin, MD, DMSc University Hospital Koge
Principal Investigator: Peter K Bonfils, MD University Hospital Koge
Study Director: Knud H Stokholm, MD University Hospital Koge
  More Information

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 Submitted: January 13, 2010
First Posted: January 14, 2010
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