NCT02252783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
4 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

September 25, 2014

Last Update Submit

July 31, 2018

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Up to 10 days

Study Arms (1)

BFPET

EXPERIMENTAL

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

Interventions

BFPETDRUG

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.

Also known as: FTPP FluorophenylTriPhenylPhosphonium
BFPET

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Georges El Fakhri, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ed Lyons

CONTACT

973-744-1565ELyons@Fluoropharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 30, 2014

Study Start

October 1, 2018

Primary Completion

May 30, 2019

Study Completion

September 30, 2019

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)