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

This study has been completed.
Sponsor:
Collaborator:
University Hospital Koge
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT01049087
First received: January 13, 2010
Last updated: March 19, 2013
Last verified: January 2010
  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 Blind (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 Roskilde County Hospital:

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

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049087

Locations
Denmark
University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine
Koge, Denmark, DK-4600
Sponsors and Collaborators
Roskilde County 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

No publications provided

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
Study First Received: January 13, 2010
Last Updated: March 19, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Roskilde County Hospital:
plasma volume
technetium-labeled albumin
radioiodine-labeled albumin
Healthy volunteers

ClinicalTrials.gov processed this record on April 17, 2014