BFPET for Regional Myocardial Perfusion Imaging

NCT ID: NCT02252783

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

BFPET

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

FTPP FluorophenylTriPhenylPhosphonium

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
• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fluoropharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georges El Fakhri, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Ed Lyons

Role: CONTACT

ELyons@Fluoropharma.com

973-744-1565

Other Identifiers

BFPET P-02

Identifier Type: -

Identifier Source: org_study_id