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A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
This study has been completed.
First Received: August 12, 2008   No Changes Posted
Sponsored by: Fluoropharma, Inc.
Information provided by: Fluoropharma, Inc.
ClinicalTrials.gov Identifier: NCT00733460
  Purpose

Safety and dosimetry for BFPET™ will be evaluated in healthy volunteers, male or female and of age ranging between 20-80 years old. Six healthy subjects will undergo whole body imaging for biodistribution and dosimetry estimation. Another six healthy subjects will undergo heart imaging only, in order to evaluate the performance of BFPET as an imaging agent.


Condition Intervention Phase
Coronary Artery Disease
Drug: BFPET
Phase I

MedlinePlus related topics: Coronary Artery Disease Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Fluoropharma, Inc.:

Primary Outcome Measures:
  • To evaluate the safety, biodistribution, and radiation dosimetry of BFPET in healthy volunteers.

Secondary Outcome Measures:
  • The evaluation of the performance characteristics of BFPET as a PET tracer for myocardial imaging.
  • Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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

Inclusion Criteria:

  • Subjects must meet all of the following criteria to be enrolled in the study:

    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:

  • Subjects having any of the following criteria at the time of enrollment will be excluded from study entry:

    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.
  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: Alan J Fischman, M.D., Ph.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

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

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on May 07, 2009