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

Fluoropharma, Inc.1 site in 1 country40 target enrollmentOctober 1, 2018

ConditionsCoronary Artery Disease

InterventionsBFPET

DrugsBFPET

Overview

Phase: Phase 2
Intervention: BFPET
Conditions: Coronary Artery Disease
Sponsor: Fluoropharma, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Sensitivity and specificity of BFPET
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2018

End Date

September 30, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fluoropharma, Inc.

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Arms & Interventions

BFPET

BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq).

Intervention: BFPET