A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BFPET
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring BFPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Radiation Dosimetry
Eligibility Criteria
NORMAL HEALTHY VOLUNTEERS Inclusion Criteria
- Subject must provide written informed consent prior to any study related procedures;
- Subject must be ≥ 20 and ≤ 80 years of age;
- Subject must have a serum creatinine within the investigational site's normal range.
- Subject must have liver function tests < 1.5 times the investigational site's normal range.
- Subject must have a hematocrit level within 5% of the investigational site's normal range.
Exclusion Criteria:
- 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;
- Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
- Any exposure to investigational 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 Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
- Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.
CORONARY ARTERY DISEASE (CAD) SUBJECTS
Inclusion Criteria:
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 20 and ≤ 80 years of age;
- Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
Exclusion Criteria:
- 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 6 months;
- Percutaneous coronary intervention (PCI), with stent placement within six months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- 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 canula);
- History of Diabetes Mellitus;
- Serum creatinine > 2 mg/dL;
- All cancer 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;
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BF-PET
Arm Description
Outcomes
Primary Outcome Measures
Change in blood pressure. Safety Biodistribution Radiation dosimetry
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded.
Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes.
Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
Secondary Outcome Measures
Performance characteristics of BFPET as a PET tracer for myocardial imaging.
Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733460
Brief Title
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
Official Title
A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Detailed Description
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging
Visit 3 (within 24-48 hours post dose): 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
BFPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Radiation Dosimetry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BF-PET
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BFPET
Primary Outcome Measure Information:
Title
Change in blood pressure. Safety Biodistribution Radiation dosimetry
Description
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded.
Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes.
Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
Time Frame
pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.
Secondary Outcome Measure Information:
Title
Performance characteristics of BFPET as a PET tracer for myocardial imaging.
Description
Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
Time Frame
30, 60, 120, and 240 seconds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
NORMAL HEALTHY VOLUNTEERS Inclusion Criteria
Subject must provide written informed consent prior to any study related procedures;
Subject must be ≥ 20 and ≤ 80 years of age;
Subject must have a serum creatinine within the investigational site's normal range.
Subject must have liver function tests < 1.5 times the investigational site's normal range.
Subject must have a hematocrit level within 5% of the investigational site's normal range.
Exclusion Criteria:
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;
Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
Any exposure to investigational 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 Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.
CORONARY ARTERY DISEASE (CAD) SUBJECTS
Inclusion Criteria:
Subjects must provide written informed consent prior to any study related procedures;
Subjects must be ≥ 20 and ≤ 80 years of age;
Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
Exclusion Criteria:
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 6 months;
Percutaneous coronary intervention (PCI), with stent placement within six months;
Blood pressure over 180/100;
Acute changes in ECG;
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 canula);
History of Diabetes Mellitus;
Serum creatinine > 2 mg/dL;
All cancer 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Gewirtz, M.D.
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
Learn more about this trial
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
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