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BFPET for Regional Myocardial Perfusion Imaging

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BFPET

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BFPET

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02252783

First Posted

September 25, 2014

Last Updated

July 31, 2018

Sponsor

Fluoropharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02252783

Brief Title

BFPET for Regional Myocardial Perfusion Imaging

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Anticipated)

Primary Completion Date

May 30, 2019 (Anticipated)

Study Completion Date

September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fluoropharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BFPET

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BFPET

Other Intervention Name(s)

FTPP FluorophenylTriPhenylPhosphonium

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity and specificity of BFPET

Description

To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.

Time Frame

Up to 30 days

Secondary Outcome Measure Information:

Title

Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments

Description

Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration

Time Frame

Up to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ed Lyons

Phone

973-744-1565

ELyons@Fluoropharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georges El Fakhri, Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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