A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00413647 |
Recruitment Status
:
Completed
First Posted
: December 20, 2006
Last Update Posted
: June 12, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Drug: CardioPET | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 21 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: CardioPET | Drug: CardioPET |
- 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). ]Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
- 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. ]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. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413647
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Alan J. Fischman, MD, PhD | Massachusetts General Hospital |
Additional Information:
Responsible Party: | Fluoropharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00413647 History of Changes |
Other Study ID Numbers: |
CardioPET P-01 |
First Posted: | December 20, 2006 Key Record Dates |
Last Update Posted: | June 12, 2013 |
Last Verified: | June 2013 |
Keywords provided by Fluoropharma, Inc.:
CardioPET Coronary Artery Disease Electrocardiogram Radiation Dosimetry |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |