A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease

June 10, 2013 updated by: Fluoropharma, Inc.

A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease

Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.

Study Procedures:

Visit 1: Screening - Eligibility determination

Visit 2: Injection and PET Imaging

Visit 3: Follow-up Visit

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Normal Healthy Volunteers:

  • Subject must provide written informed consent prior to any study related procedures
  • Subjects must be between the ages of 50 and 85 years of age.

Coronary Artery Disease (CAD) subjects:

  • Subjects must provide written informed consent prior to any study related procedures;
  • Subjects must be ≥ 50 and ≤ 85 years of age;
  • Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.

Exclusion Criteria:

Normal Healthy Volunteers:

  • Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
  • Any clinically significant abnormality in the screening laboratory tests or ECG
  • Fasting blood glucose level over 120 mg/dl
  • Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
  • Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
  • Any new prescription medications within four(4)weeks of Visit 1
  • Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH

Coronary Artery Disease (CAD) Subjects:

  • Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
  • Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
  • Coronary artery bypass graft (CABG) within 1 year;
  • Percutaneous coronary intervention (PCI), with stent placement within three months;
  • Blood pressure over 180/100;
  • Acute changes in ECG;
  • Cardiac ischemia identified by MPI stress test;
  • Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
  • Any implanted pacemaker or defibrillator use within the last three months;
  • Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canola);
  • History of Diabetes Mellitus;
  • Serum creatinine > 2 mg/dL;
  • All cancer and or chemotherapy patients;
  • Body Mass Index (BMI) is over 35;
  • Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
  • Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;
  • High daily alcohol consumption over 4 alcohol drinks per day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CardioPET
Drug: CardioPET

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
Time Frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Time Frame: 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.
0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data
Time Frame: Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.
Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fluoropharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alan J. Fischman, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CardioPET P-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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