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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
United States
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, Electrocardiogram, Radiation Dosimetry

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CardioPET

Arm Description

Outcomes

Primary Outcome Measures

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.
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.

Secondary Outcome Measures

Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.
Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data

Full Information

First Posted
December 18, 2006
Last Updated
June 10, 2013
Sponsor
Fluoropharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00413647
Brief Title
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
Official Title
A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fluoropharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

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, Electrocardiogram, Radiation Dosimetry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CardioPET
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CardioPET
Primary Outcome Measure Information:
Title
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.
Description
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
Time Frame
Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Secondary Outcome Measure Information:
Title
Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Description
Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.
Time Frame
0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J. Fischman, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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