A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413647
• Other study ID #: CardioPET P-01
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2006
• Last updated: June 10, 2013
• Start date: September 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2013
• Source: Fluoropharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.

Description:

CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.

Study Procedures:

Visit 1: Screening - Eligibility determination

Visit 2: Injection and PET Imaging

Visit 3: Follow-up Visit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

Normal Healthy Volunteers:

• Subject must provide written informed consent prior to any study related procedures

• Subjects must be between the ages of 50 and 85 years of age.

Coronary Artery Disease (CAD) subjects:

• Subjects must provide written informed consent prior to any study related procedures;

• Subjects must be = 50 and = 85 years of age;

• Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.

Exclusion Criteria:

Normal Healthy Volunteers:

• Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination

• Any clinically significant abnormality in the screening laboratory tests or ECG

• Fasting blood glucose level over 120 mg/dl

• Any exposure to any investigational drugs with four(4)weeks prior to Visit 1

• Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1

• Any new prescription medications within four(4)weeks of Visit 1

• Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH

Coronary Artery Disease (CAD) Subjects:

• Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;

• Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;

• Coronary artery bypass graft (CABG) within 1 year;

• Percutaneous coronary intervention (PCI), with stent placement within three months;

• Blood pressure over 180/100;

• Acute changes in ECG;

• Cardiac ischemia identified by MPI stress test;

• Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;

• Any implanted pacemaker or defibrillator use within the last three months;

• Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canola);

• History of Diabetes Mellitus;

• Serum creatinine > 2 mg/dL;

• All cancer and or chemotherapy patients;

• Body Mass Index (BMI) is over 35;

• Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;

• Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;

• High daily alcohol consumption over 4 alcohol drinks per day.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• CardioPET

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fluoropharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.	Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.	Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).	Yes
Secondary	Performance characteristics of CardioPET as a PET tracer for myocardial imaging.	Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.	0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.	No
Secondary	Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data		Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.	No

External Links

•   Click here for more information about CardioPET P-01