NCT00891241

Brief Summary

The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

April 29, 2009

Last Update Submit

November 12, 2020

Conditions

Heart Failure

Keywords

Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry

Outcome Measures

Primary Outcomes (1)

  • Safety of LMI 1195 in terms of treatment-related adverse events

    Number of study subjects exhibiting treatment-related adverse events

    14 days

Secondary Outcomes (1)

  • Radiation Dosimetry of a single dose of LMI 1195

    2 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Healthy Population

Drug: LMI 1195-101

Cohort 2

EXPERIMENTAL

Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement

Drug: LMI 1195-101

Interventions

LMI 1195-101DRUG

Single dose, bolus IV injection of LMI 1195

Also known as: LMI 1195-101 Clinical Trial
Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, age 18-40

You may not qualify if:

  • Significant or chronic medical illness
  • Pregnant females
  • Smoking within one month of enrollment
  • Use of any prescription drugs within 4 weeks prior to dosing
  • year old subjects with a diagnosis of NYHA Class II-III heart failure
  • Ejection fraction less than or equal to 35%
  • Rest SPECT imaging within 90 days prior to enrollment
  • Significant or chronic medical illness
  • Pregnant females
  • Known history of arrhythmogenic disorder or rhythm disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University Medical Center

New Haven, Connecticut, 06250, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • L. Veronica Lee, M.D.

    Medical Monitor - Lantheus Medical Imaging

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

US(2)