BFPET for Regional Myocardial Perfusion Imaging

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: BFPET

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fluoropharma, Inc.
• Investigators: Principal Investigator: Georges El Fakhri, Ph.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Heart Diseases; Myocardial Ischemia; Coronary Disease; Arterial Occlusive Diseases
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BFPET P-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No