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

NCT01826773 | Completed Phase 2 FDA Drug

• 2 other identifiers: CardioPET™ P-022012-002261-36
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease

Keywords

CardioPET; Coronary Artery Disease; Myocardial Perfusion Imaging; Coronary Angiography; Myocardial Fatty Acid Utilization

Outcome Measures

Primary Outcomes (1)

• 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).

  One year

Secondary Outcomes (1)

• 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

  Baseline (pre-injection) values to Post-injection values

Study Arms (2)

Stress only CardioPET™

EXPERIMENTAL

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™

Rest only CardioPET™

EXPERIMENTAL

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™

Interventions

CardioPET™ DRUG

CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).

Also known as: trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid, FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)

Rest only CardioPET™; Stress only CardioPET™

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fluoropharma, Inc.: lead

Study Sites (5)

Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst

Aalst, Belgium

Location

Departement de Cardiologie, CU Saint-Luc

Brussels, Belgium

Location

Service de Medicine Nucleaire, CHU Erasme

Brussels, Belgium

Location

Nucleaire Geneesunde Gasthuisberg Leuven Hospital

Leuven, Belgium

Location

Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium

Liège, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

9-fluoro-3,4-methyleneheptadecanoic acid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Olivier Gheysens, Professor

  Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

BE (5)