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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: CardioPET

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CardioPET	Drug: CardioPET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Fluoropharma, Inc.
• Investigators: Principal Investigator: Alan J. Fischman, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Electrocardiogram; CardioPET; Radiation Dosimetry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CardioPET P-01