A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET

A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: BFPET

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

NORMAL HEALTHY VOLUNTEERS Inclusion Criteria

1. Subject must provide written informed consent prior to any study related procedures;
2. Subject must be ≥ 20 and ≤ 80 years of age;
3. Subject must have a serum creatinine within the investigational site's normal range.
4. Subject must have liver function tests < 1.5 times the investigational site's normal range.
5. Subject must have a hematocrit level within 5% of the investigational site's normal range.

Exclusion Criteria:

1. Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination;
2. Any clinically significant abnormality in the screening laboratory tests or ECG;
3. Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
4. Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1;
5. Any new prescription medications within four (4) weeks of Visit 1;
6. 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.
7. Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.

CORONARY ARTERY DISEASE (CAD) SUBJECTS

Inclusion Criteria:

1. Subjects must provide written informed consent prior to any study related procedures;
2. Subjects must be ≥ 20 and ≤ 80 years of age;
3. 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:

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;
2. Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
3. Coronary artery bypass graft (CABG) within 6 months;
4. Percutaneous coronary intervention (PCI), with stent placement within six months;
5. Blood pressure over 180/100;
6. Acute changes in ECG;
7. Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
8. Any implanted pacemaker or defibrillator use within the last three months;
9. 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);
10. History of Diabetes Mellitus;
11. Serum creatinine > 2 mg/dL;
12. All cancer patients;
13. Body Mass Index (BMI) is over 35;
14. Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
15. Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BF-PET	Drug: BFPET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
Performance characteristics of BFPET as a PET tracer for myocardial imaging.	Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress	30, 60, 120, and 240 seconds.

Collaborators and Investigators

• Sponsor: Fluoropharma, Inc.
• Investigators: Principal Investigator: Henry Gewirtz, M.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Myocardial Perfusion Imaging; Radiation Dosimetry; BFPET
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BFPET P-01