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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fluoropharma, Inc.
ClinicalTrials.gov Identifier:
NCT00413647
First received: December 18, 2006
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: CardioPET
Phase 1

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

Further study details as provided by Fluoropharma, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events). ] [ Designated as safety issue: Yes ]
    Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.


Secondary Outcome Measures:
  • Performance characteristics of CardioPET as a PET tracer for myocardial imaging. [ Time Frame: 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min. ] [ Designated as safety issue: No ]
    Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.

  • Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardioPET 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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00413647

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Fluoropharma, Inc.
Investigators
Principal Investigator: Alan J. Fischman, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Fluoropharma, Inc.
ClinicalTrials.gov Identifier: NCT00413647     History of Changes
Other Study ID Numbers: CardioPET P-01
Study First Received: December 18, 2006
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fluoropharma, Inc.:
CardioPET
Coronary Artery Disease
Electrocardiogram
Radiation Dosimetry

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014