A Multicenter, Phase II, Open Label Trial to Determine Optimal Imaging Parameters and Assess the Safety of LMI 1195 in Low Risk Patients and Heart Failure Patients With a History of Firing of an Implantable Cardioverter-Defibrillator

Lantheus Medical Imaging1 site in 1 countryMay 2010

ConditionsHeart Failure

InterventionsLMI 1195

DrugsLMI 1195

Overview

Phase: Phase 2
Intervention: LMI 1195
Conditions: Heart Failure
Sponsor: Lantheus Medical Imaging
Locations: 1
Primary Endpoint: Dose acquisition time product, target and non-target F18 count density
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.

Detailed Description

* To determine the optimal imaging protocol for a single dose of LMI1195 during positron emission tomography (PET) for the intended study population. * To assess the safety and tolerability of LMI1195 in patients at low risk of ventricular arrhythmia ("low risk patients") and heart failure patients with a history of firing of an implantable cardioverter defibrillator (ICD) within 6 months prior to enrollment, a documented ejection fraction (EF) ≤ 35%, and a prior diagnosis of NYHA Class II-III heart failure ("heart failure patients") who are undergoing PET imaging.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

February 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lantheus Medical Imaging

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant female ≥ 18 years of age
•a body weight that is \<450 pounds
•Be able to lie flat for at least 2-hour intervals
•Have a normal left ventricular ejection fraction (i.e., ≥ 55% for cohort one or ≤35% for cohort two) by multiple gate acquisition scan (MUGA), echocardiogram or single photon emission computed tomography (SPECT) within 90 days prior, but no less than 3 days prior to enrollment.
•Have been scheduled to undergo or have undergone a SPECT or an approved PET perfusion imaging study performed within 90 days prior to, but no less than 3 days prior to enrollment. to and within the study timeline must be reviewed and deemed acceptable by the judgment of the investigator) (Additional More Specific Criteria can be accessed by contacting an LMI representative)

Exclusion Criteria

•Have a history of diabetes, coronary artery disease, myocardial infarction heart arrhythmia (except sinus arrhythmia), heart failure, cardiomyopathy (e.g. restrictive, infiltrative or hypertrophic cardiomyopathy), constrictive pericarditis, myocarditis, complex congenital disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease, pacemaker, syncope, transient ischemic attack (TIA) or cerebrovascular accident (CVA), Parkinson's disease, degenerative cerebral disease, or organ transplantation.significant comorbid conditions
•Have undergone major surgery within 4 weeks prior to enrollment or planned within 3 weeks after completion of the study.
•Unexplained syncope within 5 years.
•A life expectancy of \< 1 year, from any cause.
•Are currently participating in another clinical trial of an investigational product.
•Have clinically significant laboratory abnormalities (e.g., liver enzymes, creatinine, etc.).
•Have a history of smoking within 1 month of enrollment.
•History of drug or alcohol abuse
•Have a history of major psychiatric disorder, active alcohol/drug abuse, and/or history of non-compliance.
•Receipt of any radiopharmaceutical within a period equal to 10 half-lives of the isotope (e.g., for 99mTc, a period of 60 hours; for 111In, a period of 28 days) prior to enrollment or receipt of any radiopharmaceutical containing iodine within a period of 3 months prior to enrollment.

Arms & Interventions

Cohort 1

Low risk Heart Failure patients

Intervention: LMI 1195

Cohort 2

High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing

Intervention: LMI 1195

Outcomes

Primary Outcomes

Dose acquisition time product, target and non-target F18 count density

Time Frame: Approximately one year

Secondary Outcomes

Assess Image Quality Data Variability across age & sex stratification Determine Retention Index Values Determine Heart to Mediastinal Ratio Evaluate additional image derived markers that may have predictive value(Approximately one year)