BFPET for Regional Myocardial Perfusion Imaging

Phase 2

• Conditions: Coronary Artery Disease
• Interventions: Drug: BFPET

• Registration Number: NCT02252783
• Lead Sponsor: Fluoropharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Study Start: 2018-10-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BFPET	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States