HealthyNCT01049087
Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
A study testing Plasma volume determination (99mTc-albumin) and Plasma volume determination (125I-albumin) in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Plasma volume determination (99mTc-albumin) and Plasma volume determination (125I-albumin)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 27 kg/m2
- Written informed consent
Who cannot join
- Hypertension (140/90 mmHg)
- Diabetes mellitus
- Any use of medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine
Køge, DK-4600
About this study
Official title: Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
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.
Read the 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
- Being tested
- Plasma volume determination (99mTc-albumin), Plasma volume determination (125I-albumin)
- Keywords
- plasma volume, technetium-labeled albumin, radioiodine-labeled albumin, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma volume determination (99mTc-albumin)Radiation
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)Radiation
The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin
Measured: January 2011
Secondary outcomes (1)
Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation
Measured: January 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Steen Levin, MD, DMSc, Study chair, Zealand University HospitalPeter K Bonfils, MD, Principal investigator, Zealand University HospitalKnud H Stokholm, MD, Study director, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049087
- Sponsor's protocol ID
- SJ-112
- Status last verified
- Jan 2010
- First submitted
- 13 Jan 2010
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
- ClinicalTrials.gov ID
- NCT01049087
- Acronym / sponsor ID
- SJ-112
- Conditions
- Healthy
- Keywords
- plasma volume, technetium-labeled albumin, radioiodine-labeled albumin, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI < 27 kg/m2
- Written informed consent
Key exclusion criteria (4 listed)
- Hypertension (140/90 mmHg)
- Diabetes mellitus
- Any use of medication
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | – |
Primary outcome
Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin
Time frame: January 2011
1 secondary outcome
Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation
Time frame: January 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Levin, MD, DMSc study chair
Zealand University Hospital
Peter K Bonfils, MD principal investigator
Zealand University Hospital
Knud H Stokholm, MD study director
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma volume determination (99mTc-albumin) and Plasma volume determination (125I-albumin) in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin (time frame: January 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.