Phase 2
N=33
Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT00849108 ↗Enrolled (actual)
33
Serious AEs
1.1%
Results posted
Jan 2015
Primary outcome: Primary: Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product — 100 MBq X Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS747158 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lantheus Medical Imaging
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product |
100 | — |
| PRIMARY Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity |
0.769; 0.596 | 0.02 sig |
| PRIMARY Cohort 1: Determination of Ratio of Stress Dose to Rest Dose |
0.228 | — |
| PRIMARY Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity |
0.877; 0.836 | 0.317 |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00849108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.