BFPET for Regional Myocardial Perfusion Imaging

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02252783
• Other study ID #: BFPET P-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2018
• Source: Fluoropharma, Inc.
• Contact: Ed Lyons
• Phone: 973-744-1565
• Email: ELyons[@]Fluoropharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fluoropharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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