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

Lantheus Medical Imaging

Status and phase: Completed; Phase 2

Conditions: Ischemia

Treatments: Drug: BMS747158

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849108

BMS747158-201

Details and patient eligibility

About

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.

Full 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

Enrollment: 176 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Cohort 1: dose range and dose interval

Experimental group

Description:

Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.

Treatment:

Drug: BMS747158

Cohort 2: Pharm&exercise stress Efficacy

Experimental group

Description:

Patients to receive 2 IV bolus injections of BMS747158:1 at rest and 1 at stress For the Pharmacologic (Adenosine) Stress: * Doses at rest to range between 2.9 and 3.4 mCi. * Doses under stress 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.

Treatment:

Drug: BMS747158