Coronary Heart DiseaseOSPECTNCT05146323
Optimization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging
An observational study of Coronary Heart Disease, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2021to 24 Sep 2021
- 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: Patient with myocardial perfusion Imaging in the context of coronary heart disease
Who may be able to join
- Patient underwent stress-test 99 mTc-Sestamibi SPECT/CT myocardial perfusion Imaging on a Siemens Intevo Bold Anger camera with the cardiofocal SmartZoom® collimator
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging With the Cardiofocal SmartZoom® Collimator
This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.
- Conditions
- Coronary Heart Disease
- Keywords
- Myocardial SPECT, Sestamibi, SmartZoom, Cardiofocal collimator, Dose optimization
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of counts
Number of counts in the myocardial region of interest
Measured: Day 1
Secondary outcomes (1)
Clinical evaluation
Medical evaluation of image quality, in order to establish a correlation between the myocardial signal level and the clinical image quality
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start11 Feb 2021
- Primary completion30 Jun 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146323
- Sponsor's protocol ID
- 2021-06Obs-CHRMT
- Acronym
- OSPECT
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging With the Cardiofocal SmartZoom® Collimator
- ClinicalTrials.gov ID
- NCT05146323
- Acronym / sponsor ID
- OSPECT / 2021-06Obs-CHRMT
- Conditions
- Coronary Heart Disease
- Keywords
- Myocardial SPECT, Sestamibi, SmartZoom, Cardiofocal collimator, Dose optimization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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.
This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with myocardial perfusion Imaging in the context of coronary heart disease
Key inclusion criteria (1 listed)
- Patient underwent stress-test 99 mTc-Sestamibi SPECT/CT myocardial perfusion Imaging on a Siemens Intevo Bold Anger camera with the cardiofocal SmartZoom® collimator
Key exclusion criteria (1 listed)
- None
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
Number of counts
Time frame: Day 1
Number of counts in the myocardial region of interest
1 secondary outcome
Clinical evaluation
Time frame: Day 1
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 6 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Heart Disease, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 1 inclusion and 1 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 6 Dec 2021. 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 France. 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.
What does the primary outcome measure?
Number of counts (time frame: Day 1). 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 6 Dec 2021.