Clinical Trials

CardioPET [F-18] FCPHA

Phase I

FluoroPharma completed the Phase I clinical trial for CardioPET in March 2008. The trial enrolled 15 normal healthy volunteers and 6 subjects with CAD to evaluate safety, distribution and dosimetry of CardioPET as a PET tracer for myocardial imaging. The trial was a single center, open label study led by Principal Investigator Alan J. Fischman, MD, PhD at the Massachusetts General Hospital.

The CardioPET trial achieved all safety endpoints with no adverse events or clinically significant changes noted in follow-up clinical and laboratory testing. The agent had rapid extraction from blood with sustained levels in myocardium. CardioPET performed well in both healthy volunteers and patients with CAD.

Analysis by H. William Strauss, MD, the trial's medical monitor, suggests that CardioPET has promise as a PET agent for assessing integrity of the heart. The CardioPET images showed good contrast between lesion and normal myocardium, and compared to SPECT, may be superior in quality.

Phase II

A Phase II clinical study was initiated in February of 2013 and completed enrollment in December of 2014. The study was conducted at four clinical imaging sites in Belgium.

Subjects were assigned one of two groups: Group I - Stress only, Group II - Rest only. Both groups underwent a 60-minute list mode PET/CT imaging following 18-F FCPHA injection within 48hrs-10days after their initial qualifying stress test. Physical exam, vital signs, 12-lead ECG, hematology, chemistry and urinalysis, were collected at baseline (day of study), at one hour after dosing with study drug and at 24-hours. Monitoring of vital signs via 3-lead ECG continued for 60-minutes during PET imaging.

34 subjects were enrolled, and 31 subjects received CardioPET. The dose of CardioPET (up to 10mCi) was well tolerated, and there were no serious adverse events (SAE's) reported by investigators. Segmental analysis of PET and SPECT images were performed by an experienced reader and adjudicated against coronary angiography.

BFPET [F-18] FTPP

FluoroPharma completed the Phase I clinical trial for BFPET in July 2008. The trial enrolled 12 normal healthy volunteers to evaluate safety, distribution and dosimetry of BFPET as a PET tracer for myocardial imaging. Myocardial perfusion imaging is a standard test to assess coronary artery disease (CAD), with more than 9 million Americans undergoing the test annually. The trial was a single center, open label study led by Principal Investigator Alan J. Fischman, MD, PhD at the Massachusetts General Hospital.

The BFPET Phase I trial achieved all safety endpoints with no adverse events or clinically significant changes noted in follow-up clinical and laboratory testing. The agent has a favorable dosimetry and pharmacokinetics profile and is well tolerated. Biodistribution results indicate fast blood clearance, rapid and stable myocardial uptake and high heart to background ratios.

A Phase II study was defined and is pending initiation at a single clinical imaging site to evaluate the performance of this PET tracer for evaluation of coronary artery disease in comparison to SPECT, the current standard of care.