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
|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.
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)|
|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|
|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. ]
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|