CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Fluoropharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Fluoropharma, Inc.
ClinicalTrials.gov Identifier:
NCT01826773
First received: April 4, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

The study is designed to evaluate how safe and how well an investigational imaging product CardioPET™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.


Condition Intervention Phase
Coronary Artery Disease
Drug: CardioPET™
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Open-Labeled Study to Evaluate CardioPET™ as a PET Imaging Agent for Evaluation of Myocardial Perfusion and Fatty Acid Uptake in Subjects With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Fluoropharma, Inc.:

Primary Outcome Measures:
  • Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™ [ Time Frame: One year ] [ Designated as safety issue: No ]

    The aim of this clinical protocol is to study CardioPET™ as a PET imaging agent for evaluation of myocardial perfusion in subjects with known or suspected CAD with a single injection of CardioPET™.

    The primary efficacy endpoint for this phase II study is the sensitivity and specificity of CardioPET™ compared to Myocardial Perfusion Imaging (MPI) using coronary angiography as the standard of reference for the detection of Coronary Artery Disease (CAD).



Secondary Outcome Measures:
  • Primary safety endpoints comparing baseline (pre-injection) values to post-injection values for laboratory testing, electrocardiograms, serial QT, and QTc measurements, physical examinations, vital signs and adverse event assessments [ Time Frame: Baseline (pre-injection) values to Post-injection values ] [ Designated as safety issue: Yes ]
    • Laboratory Testing- hematology, serum chemistry and urine analysis
    • Electrocardiograms, Serial QT and QTc measurements
    • Physical Examinations
    • Vital signs-heart rate and systolic and diastolic blood pressure
    • Adverse Event Assessments o


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress only CardioPET™

Group I will consist of 15-20 patients and will have CardioPET™ imaging performed with a repeat identical stress component at ≥ 48 hours and ≤ 10 days after the initial stress MPI study. There should be no intervention or change in symptoms between the tests, and the patient must have an angiography scheduled to be performed within 30 days.

The analysis of the acquired imaging data will determine if CardioPET™ is suitable for identifying myocardial flow defects that were observed in exercise or pharmacologic stress Tc-99m MPI imaging. The goal for this CardioPET™ imaging group is to measure blood flow at near maximal stress.

Drug: CardioPET™
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
Other Names:
  • trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid
  • FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)
Experimental: Rest only CardioPET™

Group II will consist of 15-20 subjects will have undergone either, stress, Tc-99m MPI study or stress-echocardiography indicating ≥2 segments of ischemia. These patients must have been referred and scheduled for coronary angiography. If initial evaluation was performed with stress echocardiography, subjects will have either exercise or pharmacologic stress MPI.

CardioPET™ imaging in these subjects must be performed ≥ 48 hours and ≤ 10 days from the initial stress (stress MPI or echocardiography) at rest only. An angiography must be scheduled to be performed within 30 days.

Drug: CardioPET™
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
Other Names:
  • trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid
  • FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)

Detailed Description:

The open label, phase II, multi center, study objectives are as follows:

  • To evaluate the diagnostic performance of CardioPET™ in assessing myocardial perfusion as compared to standard Tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for CAD.
  • To evaluate the safety of CardioPET™ in known or suspected CAD subjects.
  • A secondary objective is to assess fatty acid uptake at rest and following stress.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must provide written informed consent prior to any study related procedures;
  • Male and female subjects over 30 years of age with known or suspected CAD;
  • Subjects have been evaluated as having known or suspected CAD by either exercise or pharmacologic MPI or echocardiography with ≥2 segments of ischemia and have been referred to coronary angiography for known or suspected CAD;
  • Subjects must be able to complete all evaluations within 30 days of Tc-99m MPI imaging, and must be without any intervention or change in symptoms between the tests.

Exclusion Criteria:

  • Past or present use of medications that target fatty acid uptake or metabolism, e.g. Ranexa® (Ranolazine);
  • Acute changes in comparison to most recent ECG;
  • Suspected acute coronary syndrome;
  • Chronic renal failure (Cr > 2.5);
  • Anemia (Hgb < 10 within past 2 weeks);
  • NYHA Class III or IV Congestive heart failure;
  • Severe heart valve disease;
  • Any exposure to any investigational drugs or devices, within 30 days prior to imaging study;
  • Any acute or unstable physical or psychological disease judged by the Investigators based on medical history or screening physical examination;

Female subjects only:

  • Subject that has a positive 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 CardioPET™ administration.

Male subjects:

  • Reliable contraception method from the first injection with the tracer until 3 months after the last injection with the tracer. The following contraceptive method(s) is (are) allowed during the study: Condom.
  • If your partner becomes pregnant during the study, you should immediately report this to the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826773

Contacts
Contact: Olivier Gheysens, Professor +32-16-34.25.25 67 olivier.gheysens@uzleuvens.be
Contact: Roland Hustinx, Professor +32 43 66 72 00 rhustinx@chu.ulg.ac.be

Locations
Belgium
Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst Recruiting
Aalst, Belgium
Contact: Pieter De Bondt, M.D.    +32 53 72 44 77    Pieter.De.Bondt@olvz-aalst.be   
Principal Investigator: Pieter De Bondt, M.D.         
Service de Medicine Nucleaire, CHU Erasme Recruiting
Bruxelles, Belgium
Contact: Serge Goldman, M.D.    +32 2 5554711    sgoldman@ulb.ac.be   
Principal Investigator: Serge Goldman, M.D.         
Departement de Cardiologie, CU Saint-Luc Recruiting
Bruxelles, Belgium
Contact: David Vancraeynest, M.D.    +32 2 764 28 03    david.vancraeynest@uclovain.be   
Principal Investigator: David Vancraeynest, M.D.         
Nucleaire Geneesunde Gasthuisberg Leuven Hospital Recruiting
Leuven, Belgium
Contact: Olivier Gheysens, Professor    +32-16-34.25 67    olivier.gheysens@uzleuven.be   
Principal Investigator: Olivier Gheysens, Professor         
Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium Recruiting
Liege, Belgium
Contact: Roland Hustinx, M.D.    +32 43 66 72 00    rhustinx@chu.ulg.ac.be   
Principal Investigator: Roland Hustinx         
Sponsors and Collaborators
Fluoropharma, Inc.
Investigators
Principal Investigator: Olivier Gheysens, Professor Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Fluoropharma, Inc.
ClinicalTrials.gov Identifier: NCT01826773     History of Changes
Other Study ID Numbers: CardioPET™ P-02, 2012-002261-36
Study First Received: April 4, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee

Keywords provided by Fluoropharma, Inc.:
CardioPET
Coronary Artery Disease
Myocardial Perfusion Imaging
Coronary Angiography
Myocardial Fatty Acid Utilization

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014