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

NCT ID: NCT00733460

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-01-31

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BF-PET

Group Type: EXPERIMENTAL

BFPET

Intervention Type: DRUG

Interventions

BFPET

Intervention Type: DRUG

Eligibility Criteria

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.

1. Subjects must provide written informed consent prior to any study related procedures;

2. Subjects must be ≥ 20 and ≤ 80 years of age;

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

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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fluoropharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Gewirtz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

BFPET P-01

Identifier Type: -

Identifier Source: org_study_id