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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fluoropharma, Inc.
ClinicalTrials.gov Identifier:
NCT00733460
First received: August 12, 2008
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: BFPET
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Fluoropharma, Inc.:

Primary Outcome Measures:
  • Change in blood pressure. Safety Biodistribution Radiation dosimetry [ 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. ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 30, 60, 120, and 240 seconds. ] [ Designated as safety issue: No ]
    Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress


Enrollment: 12
Study Start Date: March 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF-PET 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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733460

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Fluoropharma, Inc.
Investigators
Principal Investigator: Henry Gewirtz, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Fluoropharma, Inc.
ClinicalTrials.gov Identifier: NCT00733460     History of Changes
Other Study ID Numbers: BFPET P-01
Study First Received: August 12, 2008
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fluoropharma, Inc.:
BFPET
Coronary Artery Disease
Myocardial Perfusion Imaging
Radiation Dosimetry

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014