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Sponsored by: |
Lantheus Medical Imaging |
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Information provided by: | Lantheus Medical Imaging |
ClinicalTrials.gov Identifier: | NCT00849108 |
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 |
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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 |
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 |
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Dosing Interval A: Experimental
60 minute interval between rest and stress procedures on day 1
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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.
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Dosing Interval B: Experimental
120 minute interval between rest and stress procedures on day 1
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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.
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The primary objectives of this study are:
The secondary objectives of this study are:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patients must:
Exclusion Criteria:
Contact: Qi Zhu, MD | 978-671-8605 | qi.zhu@lantheus.com |
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 |
Study Director: | Qi Zhu, MD, MPH | Lantheus Medical Imaging |
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 |
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 |
Coronary Disease Stress Ischemia Coronary Artery Disease |
Pathologic Processes Ischemia |