Heart FailurePhase 1NCT00891241
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
A Phase 1 study testing LMI 1195-101 in people with Heart Failure, run by Lantheus Medical Imaging at 2 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- LMI 1195-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hartford Hospital
Hartford, Connecticut, 06102
Yale University Medical Center
New Haven, Connecticut, 06250
About this study
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
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)
- Conditions
- Heart Failure
- Being tested
- LMI 1195-101
- Keywords
- Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMI 1195-101Drug
Also called LMI 1195-101 Clinical Trial
Single dose, bolus IV injection of LMI 1195
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Healthy Population Receives: 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 Receives: Drug: LMI 1195-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LMI 1195 in terms of treatment-related adverse events
Number of study subjects exhibiting treatment-related adverse events
Measured: 14 days
Secondary outcomes (1)
Radiation Dosimetry of a single dose of LMI 1195
Radiation dose to organs defined by the MIRD model, in mGy/MBq
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- L. Veronica Lee, M.D., Study director, Medical Monitor - Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891241
- Sponsor's protocol ID
- LMI 1195 -101
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2009
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00891241
- Acronym / sponsor ID
- LMI 1195 -101
- Conditions
- Heart Failure
- Keywords
- Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: LMI 1195-101Healthy Population |
| Cohort 2 | Experimental | Drug: LMI 1195-101Heart 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMI 1195-101Also: LMI 1195-101 Clinical TrialSingle dose, bolus IV injection of LMI 1195 | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety of LMI 1195 in terms of treatment-related adverse events
Time frame: 14 days
Number of study subjects exhibiting treatment-related adverse events
1 secondary outcome
Radiation Dosimetry of a single dose of LMI 1195
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Veronica Lee, M.D. study director
Medical Monitor - Lantheus Medical Imaging
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMI 1195-101 in people with Heart Failure, run by Lantheus Medical Imaging at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of LMI 1195 in terms of treatment-related adverse events (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.