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A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LMI 1195-101
Sponsored by
Lantheus Medical Imaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Cohort 1 Inclusion:

  • Healthy, age 18-40

Cohort 1 Exclusion:

  • Significant or chronic medical illness
  • Pregnant females
  • Smoking within one month of enrollment
  • Use of any prescription drugs within 4 weeks prior to dosing

Cohort 2 Inclusion:

  • 30-70 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

Cohort 2 Exclusion:

  • Significant or chronic medical illness
  • Pregnant females
  • Known history of arrhythmogenic disorder or rhythm disorder

Sites / Locations

  • Hartford Hospital
  • Yale University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

Healthy Population

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

Outcomes

Primary Outcome Measures

Safety of LMI 1195 in terms of treatment-related adverse events
Number of study subjects exhibiting treatment-related adverse events

Secondary Outcome Measures

Radiation Dosimetry of a single dose of LMI 1195
Radiation dose to organs defined by the MIRD model, in mGy/MBq

Full Information

First Posted
April 29, 2009
Last Updated
November 12, 2020
Sponsor
Lantheus Medical Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT00891241
Brief Title
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Official Title
A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Healthy Population
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
LMI 1195-101
Other Intervention Name(s)
LMI 1195-101 Clinical Trial
Intervention Description
Single dose, bolus IV injection of LMI 1195
Primary Outcome Measure Information:
Title
Safety of LMI 1195 in terms of treatment-related adverse events
Description
Number of study subjects exhibiting treatment-related adverse events
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Radiation Dosimetry of a single dose of LMI 1195
Description
Radiation dose to organs defined by the MIRD model, in mGy/MBq
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cohort 1 Inclusion: Healthy, age 18-40 Cohort 1 Exclusion: Significant or chronic medical illness Pregnant females Smoking within one month of enrollment Use of any prescription drugs within 4 weeks prior to dosing Cohort 2 Inclusion: 30-70 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 Cohort 2 Exclusion: Significant or chronic medical illness Pregnant females Known history of arrhythmogenic disorder or rhythm disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. Veronica Lee, M.D.
Organizational Affiliation
Medical Monitor - Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale University Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06250
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

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