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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014