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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049087
• Other study ID #: SJ-112
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: March 19, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2010
• Source: Roskilde County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI < 27 kg/m2

• Written informed consent

Exclusion Criteria:

• Hypertension (140/90 mmHg)

• Diabetes mellitus

• Any use of medication

• Pregnancy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine	Koge

Sponsors (2)

Lead Sponsor	Collaborator
Roskilde County Hospital	University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin		January 2011	Yes
Secondary	Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation		January 2011	Yes