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

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: BFPET

• Registration Number: NCT00733460
• Lead Sponsor: Fluoropharma, Inc.

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

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BF-PET	BFPET	-

Primary Outcome Measures

Name	Time	Method
Change in blood pressure. Safety Biodistribution Radiation dosimetry	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.	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

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States