Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00849108
First received: January 5, 2009
Last updated: April 12, 2012
Last verified: April 2012
  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
Drug: BMS747158
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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 ]

Enrollment: 176
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Interval A
60 minute interval between rest and stress procedures on day 1
Drug: 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.
Other Name: There are no other names
Experimental: Dosing Interval B
120 minute interval between rest and stress procedures on day 1
Drug: 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.
Other Name: There are no other names

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849108

  Show 30 Study Locations
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Dana Washburn, MD, FACC Lantheus Medical Imaging
  More Information

Publications:

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00849108     History of Changes
Other Study ID Numbers: BMS747158-201
Study First Received: January 5, 2009
Last Updated: April 12, 2012
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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014