Cardiac Water and Fluoromethane Cardiac PET

Healthy Volunteers Clinical Trial

Official title:

Comparison of Cardiac Perfusion by O15-water and F17-fluoromethane PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205127
• Other study ID #: 2003-241
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 28, 2012
• Start date: January 2004
• Est. completion date: March 2004

Study information

• Verified date: August 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The researchers will use positron emission tomography (PET scans)to track the tracers as they moe through the heart and chest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 1. Age 18 to 40 years old 2. Willing to provide written informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• Cardiac PET imaging- rest and pharmacological stress

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-- implement myocardial perfusion quantification for O15-labeled water at rest and with pharmacologic stress,		assess at time of PET scan	No
Primary	-- determine the biodistribution of fluoromethane in the thorax to see if it is usable for a cardiac perfusion tracer,		assess at time of PET Scan	No
Secondary	--develop initial methods for quantification of myocardial perfusion if applicable for labeled fluoromethane.		assess at time of PET scan	No