CardiacNCT00639704
Improve Nuclear Medicine Heart Imaging, Compare MRI Results With Single Photon Emission Computed Tomography Imaging
An observational study of Cardiac, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The purpose of this study is to compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Aug 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are being evaluated for cardiac function/perfusion
Who may be able to join
- subjects scheduled for cardiac SPECT
- subjects 18 years old or older
Who cannot join
- Females who are pregnant or think that they are pregnant will be excluded in this study.
- Subjects who have a pacemaker, internal defibrillator, prostheses, artificial heart valves, cardiac stents, surgical clips, or TENS (transcutaneous electric nerve stimulator)
- Subjects who are 300 lbs and over
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Evaluation of EM-IntraSPECT Reconstruction Algorithm by Comparison of Transmission Images Reconstructed From SPECT Projections Alone With MRI Studies
The purpose of this study is to compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use.
Read the detailed description
Currently, up to one-third of all nuclear medicine studies are performed for cardiovascular disorders, and mostly are myocardial perfusion imaging (MPI) using SPECT acquisition. MPI aims at detection of acute myocardial ischemia and the scarred myocardium and it is increasingly used to plan myocardial revascularization and to assess the effectiveness of medical and surgical interventions. However, nonuniform gamma-ray attenuation in the thoracic region may severely impair the accuracy of SPECT cardiac imaging and frequently result in image artifacts. Therefore, attenuation corrected must be applied. We have derived an algorithm (called EM-IntraSPECT) that is able to reconstruct tomographic cross-sections of a patient from SPECT studies alone. The reconstructed cross-sections in turn, may be used for attenuation correction of cardiac SPECT images thus improving quality analysis based of these images. In this research we intend to continue evaluation of the new attenuation compensation algorithm and to assess the clinical usefulness of this method. These goals can be reached by comparing the patient's cross sectional anatomical data reconstructed by EM-IntraSPECT and obtained from MRI. It is proposed that 10 patients already undergoing nuclear cardiac imaging for clinical purpose, with 99mTc sestamibi or 99mTc radiolabeled red cells will be selected. These patients would be utilized to reconstruct transmission images and determination of internal anatomical structures in the thoracic region from SPECT projections alone. Further, direct and quantitative comparison of the patient's anatomy obtained by the MRI and the SPECT methods will be performed. The same algorithm would be used for reconstruction of attenuation compensated emission SPECT cardiac images. Finally, the accuracy and the clinical usefulness of this new, attenuation corrected cardiac SPECT image reconstruction would be quantitatively evaluated. All these procedures apply only to the image data and NOT the patient.
- Conditions
- Cardiac
- Keywords
- MRI, SPECT, Cardiac function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJan 1996
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiacStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Krol, State University of New York - Upstate Medical University
- Investigators
- Andrzej Krol, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639704
- Sponsor's protocol ID
- SUNYUMU 3257
- Status last verified
- Dec 2023
- First submitted
- 12 Mar 2008
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EM-IntraSPECT Reconstruction Algorithm by Comparison of Transmission Images Reconstructed From SPECT Projections Alone With MRI Studies
- ClinicalTrials.gov ID
- NCT00639704
- Acronym / sponsor ID
- SUNYUMU 3257
- Conditions
- Cardiac
- Keywords
- MRI, SPECT, Cardiac function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jan 1996 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Mar 2008 (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 compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use.
Detailed description
Currently, up to one-third of all nuclear medicine studies are performed for cardiovascular disorders, and mostly are myocardial perfusion imaging (MPI) using SPECT acquisition. MPI aims at detection of acute myocardial ischemia and the scarred myocardium and it is increasingly used to plan myocardial revascularization and to assess the effectiveness of medical and surgical interventions. However, nonuniform gamma-ray attenuation in the thoracic region may severely impair the accuracy of SPECT cardiac imaging and frequently result in image artifacts. Therefore, attenuation corrected must be applied. We have derived an algorithm (called EM-IntraSPECT) that is able to reconstruct tomographic cross-sections of a patient from SPECT studies alone. The reconstructed cross-sections in turn, may be used for attenuation correction of cardiac SPECT images thus improving quality analysis based of these images. In this research we intend to continue evaluation of the new attenuation compensation algorithm and to assess the clinical usefulness of this method. These goals can be reached by comparing the patient's cross sectional anatomical data reconstructed by EM-IntraSPECT and obtained from MRI. It is proposed that 10 patients already undergoing nuclear cardiac imaging for clinical purpose, with 99mTc sestamibi or 99mTc radiolabeled red cells will be selected. These patients would be utilized to reconstruct transmission images and determination of internal anatomical structures in the thoracic region from SPECT projections alone. Further, direct and quantitative comparison of the patient's anatomy obtained by the MRI and the SPECT methods will be performed. The same algorithm would be used for reconstruction of attenuation compensated emission SPECT cardiac images. Finally, the accuracy and the clinical usefulness of this new, attenuation corrected cardiac SPECT image reconstruction would be quantitatively evaluated. All these procedures apply only to the image data and NOT the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are being evaluated for cardiac function/perfusion
Key inclusion criteria (2 listed)
- subjects scheduled for cardiac SPECT
- subjects 18 years old or older
Key exclusion criteria (3 listed)
- Females who are pregnant or think that they are pregnant will be excluded in this study.
- Subjects who have a pacemaker, internal defibrillator, prostheses, artificial heart valves, cardiac stents, surgical clips, or TENS (transcutaneous electric nerve stimulator)
- Subjects who are 300 lbs and over
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Dec 2023.
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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.
Andrzej Krol, PhD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac, run by State University of New York - Upstate Medical University 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 3 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 14 Dec 2023. 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.
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.
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 14 Dec 2023.