Heart FailurePhase 4NCT01868841
123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
A Phase 4 study testing AdreView and Single Photon Emission Computed Tomography in people with Heart Failure and Cardiomyopathy, run by Timothy M. Bateman at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Cardiomyopathy
- What is being tested?
- AdreView and Single Photon Emission Computed Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2014
- Phase
- Phase 4
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New York Heart Association Class II or III Heart Failure
- Left ventricular ejection fraction less than or equal to 35%
Who cannot join
- Uncompensated heart failure
- Recent hospitalization within 30 days of cardiac related indications
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Imaging Technologies
Kansas City, Missouri, 64111
About this study
Official title: 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.
- Conditions
- Heart Failure, Cardiomyopathy
- Being tested
- AdreView, Single Photon Emission Computed Tomography
- Keywords
- 123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdreViewDrug
10 millicurie of AdreView (123I-mIBG)
Single Photon Emission Computed TomographyOther
Also called SPECT
| Study group | Role | What they receive |
|---|---|---|
| Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging | Active comparator | SPECT imaging of 10 millicurie of Adreview Receives: Drug: AdreView; Other: Single Photon Emission Computed Tomography |
| AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging | Active comparator | SPECT imaging of 10 millicurie of Adreview Receives: Drug: AdreView; Other: Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
H/M ratios as described will be calculated for the LFOV, and SFOV-HE data sets to determine the correlation between the two measurements. The r value, slope and intercept of this correlation will constitute the primary endpoint of this study. Specifically, we will establish the r value, slope and intercept for: LFOV-Planar vs LFOV-TOMO, LFOV-Planar vs SFOV-HE-TOMO, LFOV-TOMO vs SFOV-HE-TOMO.
Measured: 3 months post-enrollment close
Secondary outcomes (1)
Image Quality
We will investigate differences between the measurements in the SFOV-HE using the forward projections of the tomographic data and tomographic measurements of the H/M as other methods of establishing the correlation between tomographic and planar measurement of mIBG uptake.
Measured: 3 month post-enrollment close
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionOct 2014
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy M. Bateman
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor-investigator, Timothy M. Bateman, Aspire Foundation
- Investigators
- Timothy M Bateman, MD, Principal investigator, Aspire Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868841
- Sponsor's protocol ID
- 13-039
- Status last verified
- Jan 2018
- First submitted
- 14 May 2013
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging
- ClinicalTrials.gov ID
- NCT01868841
- Acronym / sponsor ID
- 13-039
- Conditions
- Heart Failure, Cardiomyopathy
- Keywords
- 123I-mIBG, AdreView, SPECT, Heart to Mediastinal Ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Timothy M. BatemanUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Jun 2013 (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 study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging | Active comparator | Drug: AdreView, Other: Single Photon Emission Computed TomographySPECT imaging of 10 millicurie of Adreview |
| AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging | Active comparator | Drug: AdreView, Other: Single Photon Emission Computed TomographySPECT imaging of 10 millicurie of Adreview |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New York Heart Association Class II or III Heart Failure
- Left ventricular ejection fraction less than or equal to 35%
Key exclusion criteria (2 listed)
- Uncompensated heart failure
- Recent hospitalization within 30 days of cardiac related indications
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 |
|---|---|---|
| AdreView10 millicurie of AdreView (123I-mIBG) | Drug | AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging, Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging |
| Single Photon Emission Computed TomographyAlso: SPECT | Other | AdreView SFOV-HE SPECT Imaging followed by LFOV Imaging, Adreview LFOV SPECT Imaging followed by SFOV-HE Imaging |
Primary outcome
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems
Time frame: 3 months post-enrollment close
H/M ratios as described will be calculated for the LFOV, and SFOV-HE data sets to determine the correlation between the two measurements. The r value, slope and intercept of this correlation will constitute the primary endpoint of this study. Specifically, we will establish the r value, slope and intercept for: LFOV-Planar vs LFOV-TOMO, LFOV-Planar vs SFOV-HE-TOMO, LFOV-TOMO vs SFOV-HE-TOMO.
1 secondary outcome
Image Quality
Time frame: 3 month post-enrollment close
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 11 Jan 2018.
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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.
Timothy M Bateman, MD principal investigator
Aspire Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AdreView and Single Photon Emission Computed Tomography in people with Heart Failure and Cardiomyopathy, run by Timothy M. Bateman at 1 site 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?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Relationship of H/M ratios obtained on LFOV and SFOV-HE systems (time frame: 3 months post-enrollment close). 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 11 Jan 2018.