BFPET for Regional Myocardial Perfusion Imaging

Sponsor

Fluoropharma, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02252783

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: BFPET	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

May 30, 2019

Anticipated Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: BFPET Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush. Other Names: FTPP FluorophenylTriPhenylPhosphonium

Arm

Intervention/Treatment

Experimental: 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).

Drug: BFPET

Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush.

Other Names:

FTPP FluorophenylTriPhenylPhosphonium

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of BFPET [Up to 30 days]
To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.

Secondary Outcome Measures

Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments [Up to 10 days]
Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.