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Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing (LMI1195-201)

This study has been withdrawn prior to enrollment.
(Sponsor is re-evaluating the clinical development path)
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01085175
First received: February 12, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: LMI 1195
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Dose acquisition time product, target and non-target F18 count density [ Time Frame: Approximately one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: May 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Low risk Heart Failure patients
Drug: LMI 1195
Single bolus intravenous injection of LMI 1195
Other Name: LMI 1195-101 Clinical Trial
Experimental: Cohort 2
High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing
Drug: LMI 1195
Single bolus intravenous injection of LMI 1195
Other Name: LMI 1195-101 Clinical Trial

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Have received any of the following medications within 30 days prior to enrollment, because of confounding effects to the autonomic nervous system: albuterol (Alupent, Ventolin within 24 hours), Dobutamine (Dobutrex), Dopamine (Intropin), Epinephrine (Adrenalin), Isoproterenol, Phenylephrine (Neo-Synephrine), Metaraminol (Aramine), Norepinephrine (Levophed), furazolidone (Furoxone), tricyclic antidepressants (Adapin, Asendin, Aventyl, Elavil, Endep, Norpramin, Pamelor, Sinequan, Surmontil, Tofranil, Vivactil), guanethidine (Ismelin), methyldopa (Aldomet). Over the counter herbs that have been reported to interact with adrenergic amines are excluded: ephedra (ma huang), St. John's wort; alfalfa; hibiscus; ginseng; angelica (dong quai); and yohimbe.
  • Are not suitable subjects for completion of any screening or trial procedures including PET, scans & laboratory testing,
  • Receipt of any radiopharmaceutical within a period of time that the agent has not decayed below background levels
  • Have metal that cannot be removed from the body located in the thorax, Receiving Class I or III antiarrhythmic drug therapy, except for amiodarone.

(Additional More Specific Criteria can be accessed by contacting an LMI representative)

  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: NCT01085175

Locations
United States, New York
Columbia University Medical College
New York, New York, United States, 10032
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Veronica Lee, M.D. Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Veronica Lee (M.D.), Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01085175     History of Changes
Other Study ID Numbers: LMI 1195-201
Study First Received: February 12, 2010
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Heart Failure,
PET Imaging,
Implantable Cardioverter-Defibrillator,
Sudden Cardiac Death

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014