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

NCT ID: NCT01049087

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• BMI < 27 kg/m2
• Written informed consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine

Principal Investigators

Steen Levin, MD, DMSc

Role: STUDY_CHAIR

Zealand University Hospital

Peter K Bonfils, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Knud H Stokholm, MD

Role: STUDY_DIRECTOR

Zealand University Hospital

Locations

University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine

Køge, , Denmark

Countries

Denmark

Other Identifiers

SJ-112

Identifier Type: -

Identifier Source: org_study_id