NCT00849108

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Ischemia

Interventions

Type	Name	Description
DRUG	BMS747158	dosages at rest and at stress were not to exceed a total of 14 mCi. Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period. Cohort 2: Patients to recieve IV bolus injections of BMS747158: For the Pharmacologic (Adenosine) Stress: * Doses at rest were to range between 2.9 and 3.4 mCi. * Doses under stress were to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi. For the Exercise Stress: * Doses at rest were to range between 1.7 and 2.0 mCi. * Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-02-23
• Last updated: 2015-10-14
• Results posted: 2015-01-19

Locations

24 sites across 1 country: United States