BFPET for Regional Myocardial Perfusion Imaging



Status:Not yet recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 85
Updated:8/3/2018
Start Date:October 1, 2018
End Date:September 30, 2019
Contact:Ed Lyons
Email:ELyons@Fluoropharma.com
Phone:973-744-1565

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A Phase II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease

BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in
subjects with known or suspected coronary artery disease (CAD) as compared to standard
nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or
suspected CAD subjects.


Inclusion Criteria:

- Subjects must provide written informed consent prior to any study related procedures;

- Subjects must be ≥ 21 and ≤ 85 years of age;

- Subjects must have known or suspected CAD documented by ≥2 segments of reversible
perfusion abnormalities on a SPECT (MPI)study

Exclusion Criteria

- Any clinically significant acute or unstable physical or psychological disease judged
by the investigators based on medical history or screening physical examination;

- Blood pressure over 180/100mmHg

- Acute changes in comparison to most recent ECG;

- Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident
(CVA), CABG or PCI

- Any pacemaker or defibrillator implanted within the last three months;

- Inability to remain in camera for approximately 60 minutes

- Bronchospasm

- Serum creatinine > 2 mg/dL;

- Cancer patients who have received chemotherapy or radiation therapy within the past 60
days.

- Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks
prior to imaging study;

- Any physical or psychological disease judged by the investigators to be incompatible
with the study, based on medical history or screening physical examination.

- NYHA Class III or IV Congestive heart failure;

- Subject has symptomatic hypotension

- Allergic or intolerant to aminophylline, nitroglycerin or metoprolol

- Allergic or intolerant to regadenoson or any of its excipients

- Prior participants in the study.

- Female subjects only: Positive serum and/or urine pregnancy test or is lactating or
the possibility of pregnancy cannot be ruled out prior to dosing.

Females not of child-bearing potential require confirmatory documentation in their medical
records or must have a negative pregnancy test within 4 hours prior to receiving the test
drug and agree to use an acceptable form of birth control for at least 30 days following
BFPET administration.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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