Healthy VolunteersNCT00205127
Cardiac Water and Fluoromethane Cardiac PET
A study testing Cardiac PET imaging- rest and pharmacological stress in people with Healthy Volunteers, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cardiac PET imaging- rest and pharmacological stress
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Mar 2004
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Age 18 to 40 years old 2. Willing to provide written informed consent
Who cannot join
- 1. A history of CAD 2. A history of active bronchospasm or asthma on theophylline bronchodilators 3. A history of any cardiac risk factors including: HTN, Diabetes, Hyperlipidemia, Smoking, and premature CAD in immediate family member 4. A history of liver disease or other significant disease 5. Females who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET
In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.
- Conditions
- Healthy Volunteers
- Being tested
- Cardiac PET imaging- rest and pharmacological stress
- Keywords
- Cardiac PET imaging, Radiopharmaceutical tracers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PET imaging- rest and pharmacological stressProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,
Measured: assess at time of PET scan
-- determine the biodistribution of fluoromethane in the thorax to see if it is usable for a cardiac perfusion tracer,
Measured: assess at time of PET Scan
Secondary outcomes (1)
--develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.
Measured: assess at time of PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles K Stone, MD, Principal investigator, Univeristy of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205127
- Sponsor's protocol ID
- 2003-241
- Status last verified
- Aug 2012
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET
- ClinicalTrials.gov ID
- NCT00205127
- Acronym / sponsor ID
- 2003-241
- Conditions
- Healthy Volunteers
- Keywords
- Cardiac PET imaging, Radiopharmaceutical tracers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 20 Sep 2005 (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.
In this study we are looking at the blood flow to the heart using two different chemical tags or tracers that give off a low level of radiation. The tracers used in this study are called O15-water and F17-fluoromethane. These tracers mix with the blood and will move through the body. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age 18 to 40 years old 2. Willing to provide written informed consent
Key exclusion criteria (1 listed)
- 1. A history of CAD 2. A history of active bronchospasm or asthma on theophylline bronchodilators 3. A history of any cardiac risk factors including: HTN, Diabetes, Hyperlipidemia, Smoking, and premature CAD in immediate family member 4. A history of liver disease or other significant disease 5. Females who are pregnant or lactating
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 |
|---|---|---|
| Cardiac PET imaging- rest and pharmacological stress | Procedure or surgery | – |
Primary outcome
-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,
Time frame: assess at time of PET scan
-- determine the biodistribution of fluoromethane in the thorax to see if it is usable for a cardiac perfusion tracer,
Time frame: assess at time of PET Scan
1 secondary outcome
--develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.
Time frame: assess at time of PET scan
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 29 Aug 2012.
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Screening Protocol
Pain
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.
Charles K Stone, MD principal investigator
Univeristy of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac PET imaging- rest and pharmacological stress in people with Healthy Volunteers, run by University of Wisconsin, Madison at 1 site in United States.
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 1 inclusion and 1 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 29 Aug 2012. 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 United States. 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?
-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress, (time frame: assess at time of PET scan). The study lists 2 primary outcomes in all. 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 29 Aug 2012.