Clinical trial NCT02252783: BFPET for Regional Myocardial Perfusion Imaging
Official title: A Phase II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lead sponsor: Fluoropharma, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of BFPET
timeFrame: Up to 30 days
Secondary outcomes:
measure: Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Georges El Fakhri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: