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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
CardioPET™
Sponsored by
Fluoropharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CardioPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Coronary Angiography, Myocardial Fatty Acid Utilization

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
  • Departement de Cardiologie, CU Saint-Luc
  • Service de Medicine Nucleaire, CHU Erasme
  • Nucleaire Geneesunde Gasthuisberg Leuven Hospital
  • Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stress only CardioPET™

Rest only CardioPET™

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™
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
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

Full Information

First Posted
April 4, 2013
Last Updated
March 8, 2017
Sponsor
Fluoropharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01826773
Brief Title
CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CardioPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Coronary Angiography, Myocardial Fatty Acid Utilization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress only CardioPET™
Arm Type
Experimental
Arm Description
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.
Arm Title
Rest only CardioPET™
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CardioPET™
Other Intervention Name(s)
trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid, FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)
Intervention Description
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™
Description
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).
Time Frame
One year
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline (pre-injection) values to Post-injection values

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Gheysens, Professor
Organizational Affiliation
Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
City
Aalst
Country
Belgium
Facility Name
Departement de Cardiologie, CU Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
Service de Medicine Nucleaire, CHU Erasme
City
Bruxelles
Country
Belgium
Facility Name
Nucleaire Geneesunde Gasthuisberg Leuven Hospital
City
Leuven
Country
Belgium
Facility Name
Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium
City
Liege
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.fluoropharma.com/
Description
Click here for more information on CardioPET™

Learn more about this trial

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

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