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Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
This study is currently recruiting participants.
Verified by Lantheus Medical Imaging, August 2009
First Received: January 5, 2009   Last Updated: August 13, 2009   History of Changes
Sponsored by: Lantheus Medical Imaging
Information provided by: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00849108
  Purpose

The main purpose of this study is to get more information on using BMS747158 (the study drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET scan which can then be compared to other images such as SPECT. The safety and quality of images will be studied.


Condition Intervention Phase
Ischemia
Other: BMS747158
Phase II

Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Open-Label, Randomized Multicenter Study for the Development of One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Primary outcome is definition of an optimized imaging interval and dose [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dosing Interval A: Experimental
60 minute interval between rest and stress procedures on day 1
Other: BMS747158
60 minute dosing interval between rest and stress images.A 1-3 mL IV bolus injection of BMS747158 will be administered on day 1 at rest (targeted to deliver between 0.5 mCi and 3.4 mCi); on day 1 during a stress procedure (targeted to deliver between 0.7 mCi and 6.5 mCi); and on day 2 (targeted to deliver between 1.5 mCi and 2.5 mCi) during a stress procedure.
Dosing Interval B: Experimental
120 minute interval between rest and stress procedures on day 1
Other: BMS747158
120 dosing interval between rest and stress imaging.A 1-3 mL IV bolus injection of BMS747158 will be administered on day 1 at rest (targeted to deliver between 0.5 mCi and 3.4 mCi); on day 1 during a stress procedure (targeted to deliver between 0.7 mCi and 6.5 mCi); and on day 2 (targeted to deliver between 1.5 mCi and 2.5 mCi) during a stress procedure.

Detailed Description:

The primary objectives of this study are:

  • To acquire data for the development of one-day rest/stress cardiac PET perfusion imaging protocols for BMS747158 with comparable diagnostic image quality to a two-day rest/stress PET protocol
  • To assess the safety of multiple doses of BMS747158

The secondary objectives of this study are:

  • To assess PET imaging parameters and image quality following administration of BMS747158 at rest and at stress (pharmacologic or exercise) same day (at different time intervals) and 16-48 hours after the rest injection
  • To assess feasibility of gated cardiac PET imaging with BMS747158 for left ventricular function assessment
  • To assess agreement of one and two day rest/stress PET imaging with BMS747158 in patients with reversible ischemia with rest/stress single photon emission computed tomography (SPECT) imaging
  • To perform a preliminary assessment of the diagnostic accuracy of one-day and two-day rest/stress PET perfusion imaging with BMS747158 as compared with invasive coronary angiography or computed tomography angiography (CTA) for detection of
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed IC prior to undergoing any study procedures
  • Be male or nonpregnant female, between the ages of 18 to 75 years, inclusive
  • Have:A rest/stress SPECT imaging study (either exercise or pharmacologic stress) within 21 days of enrollment, using 99mTc-labeled tracers and showing reversible ischemia
  • Female patients must:

    • be nonlactating,
    • no longer have child-bearing potential, either because they are post-menopausal (defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)

Exclusion Criteria:

  • Presence of any condition that may disrupt and/or increase permeability of the BBB, including multiple sclerosis, Alzheimer's disease, Parkinson's disease, acute central nervous system (CNS) infection, CNS tumor, autoimmune disease affecting the CNS, or CNS inflammatory
  • Current significant illness, pathology or physical examination or vital signs measurement-findings that could potentiate any adverse pharmacological event associated with a vasodilatory drug or any pathology that, in the opinion of the investigator, might confound the interpretation of the results of the study
  • Known hypersensitivity to adenosine, dipyridamole or aminophylline
  • Presence of any contraindications to exercise stress testing
  • History of New York Heart Association Class III or IV Congestive Heart Failure (CHF)
  • Any major surgery within 4 weeks prior to enrollment or planned within 2 weeks following completion of the 2-week telephone follow-up assessment
  • Inability to tolerate IV medication.
  • History of drug or alcohol abuse within the last year
  • Participation in any investigational drug, device, or placebo study within 6 months prior to study enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849108

Contacts
Contact: Qi Zhu, MD 978-671-8605 qi.zhu@lantheus.com

Locations
United States, California
UCLA Medical Plaza Recruiting
Los Angeles, California, United States, 90095
Contact: Jamshid Maddahi, MD     310-206-9896     jmaddahi@mednet.ucla.edu    
Contact: Yvonne Chapman, RN     (310) 825-8455     ychapman@mednet.ucla.edu    
Principal Investigator: Jamshid Maddahi, MD            
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Daniel Berman, MD     310-423-4223     Daniel.berman@cshs.org    
Contact: Johanna Kim     310-423-0796     Johanna.kim@cshs.org    
Principal Investigator: Daniel Berman, MD            
United States, Maryland
Johns Hopkins Medical Institution Recruiting
Baltimore, Maryland, United States, 21287
Contact: Frank Bengel, MD     410-955-8994     Fbengel1@jhmi.edu    
Contact: Natalie Mohammed     443-803-9420     nmohamm3@jhmi.edu    
Principal Investigator: Frank Bengel, MD            
United States, New Jersey
Holy Name Hospital Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Jacqueline Brunetti, MD     201-833-7225     brunetti@mail.holyname.org    
Contact: Jakey Patwari     201-541-6342     patwari@mail.holyname.org    
Principal Investigator: Jacqueline Brunetti, MD            
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Qi Zhu, MD, MPH Lantheus Medical Imaging
  More Information

Publications:
Bateman TM. Cardiac positron emission tomography and the role of adenosine pharmacologic stress. Am J Cardiol. 2004 Jul 22;94(2A):19D-24D; discussion 24D-25D. Review.
Beller GA. First annual Mario S. Verani, MD, Memorial lecture: clinical value of myocardial perfusion imaging in coronary artery disease. J Nucl Cardiol. 2003 Sep-Oct;10(5):529-42.
Beller GA, Bergmann SR. Myocardial perfusion imaging agents: SPECT and PET. J Nucl Cardiol. 2004 Jan-Feb;11(1):71-86. Review. No abstract available.
Beller GA, Zaret BL. Contributions of nuclear cardiology to diagnosis and prognosis of patients with coronary artery disease. Circulation. 2000 Mar 28;101(12):1465-78. Review. No abstract available.
Cerqueira MD, Verani MS, Schwaiger M, Heo J, Iskandrian AS. Safety profile of adenosine stress perfusion imaging: results from the Adenoscan Multicenter Trial Registry. J Am Coll Cardiol. 1994 Feb;23(2):384-9.
Guideri F, Ferber D, Galgano G, Isidori S, Blardi P, Pasini FL, Di Perri T. QTc interval prolongation during infusion with dipyridamole or adenosine. Int J Cardiol. 1995 Jan 27;48(1):67-73.
Glover DK, Gropler RJ. Journey to find the ideal PET flow tracer for clinical use: are we there yet? J Nucl Cardiol. 2007 Nov-Dec;14(6):765-8. No abstract available.
Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90. No abstract available.
Miyamoto MI, Vernotico SL, Majmundar H, Thomas GS. Pharmacologic stress myocardial perfusion imaging: a practical approach. J Nucl Cardiol. 2007 Apr;14(2):250-5. Review. No abstract available. Erratum in: J Nucl Cardiol. 2007Jul;14(4):628.

Responsible Party: Lantheus Medical Imaging ( Qi Zhu, MD, Senior Medical Director )
Study ID Numbers: BMS747158-201
Study First Received: January 5, 2009
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00849108     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Myocardial Perfusion
PET imaging
SPECT imaging
Coronary artery disease
Subjects that are male and nonpregnant female patients
presenting with reversible ischemia as characterized by a
rest/stress SPECT imaging study using
Technetium(99mTc)-labeled tracers

Study placed in the following topic categories:
Coronary Disease
Stress
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Ischemia

ClinicalTrials.gov processed this record on August 30, 2009