Myocardial PerfusionD-SPECT BISNCT02869126
Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera
A study testing Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel), 99mTc-Sestamibi and Thallium-201 in people with Myocardial Perfusion, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The purpose is to demonstrate the concordance of diagnostic information obtained with: 1. a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later, and 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion
- What is being tested?
- Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel), 99mTc-Sestamibi and Thallium-201
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2012to Nov 2015
- Phase
- Interventional
- 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
Who may be able to join
- > 18, without guardianship, signed informed consent
- Without contraindication for myocardial perfusion tomoscintigraphy and stress technique (dipyridamole and/or effort), according to common criteria to French Societies of Cardiology and Nuclear Medicine, as it is requested for all patients needing this routine examination
- Not in life-and-death emergency, with a stable clinical state (without cardiac insufficiency or instable coronary, without hypertension not well-stabilized under treatment)
- Effective contraceptive method for women of childbearing potential
- Weight ≤ 100 kg (> 100 kg patients need higher injected activities in order to obtain adequate image quality)
- Perfusion abnormalities on stress images
Who cannot join
- < 18
- Contraindications to stress test (effort and/or dipyridamole)
- Hypersensibility to thallium201 chloride or one of excipients
- Claustrophobic patient or incapable to stay lying down for 30 minutes
- Pregnancy or doubt of pregnancy
- Breastfeeding woman
- Weight > 100 kg
- Non affiliation to social security plan
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Médecine Nucléaire - CLCC Jean Perrin
Clermont-Ferrand
Service de Médecine Nucléaire - Hôpital de Brabois
Vandœuvre-lès-Nancy
About this study
Official title: Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera
The purpose is to demonstrate the concordance of diagnostic information obtained with:
- a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later, and
- a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest, in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.
Read the detailed description
Myocardial perfusion tomoscintigraphy is very used for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion. This examination can be performed with semiconductor gamma cameras that are more performant than conventional cameras regarding spatial resolution, detection sensitivity and energy resolution.
The amelioration of energy resolution could allow the realization of simultaneous recordings of a dye injected at rest and another injected during stress (double isotope recording), while conventional examination needs 2 different recordings, stress and rest, separated from several hours.
In this study patients undergo a conventional examination with D.SPECT camera with 2 recordings, the first after injection of a little activity of 99mTc-sestamibi at stress (≤ 100 MBq) and the second, 2 hours later, after injection at rest of a 3 time bigger activity of 99mTc-sestamibi (≤ 300 MBq). An activity of thallium-201(≤ 50 MBq) is injected at rest after the first recording of stress. 5 minutes later, a supplementary double isotope recording is realized with D.SPECT camera (99mTc-Sestamibi-stress / thallium201-rest).
The demonstration of the hypothesis of this study could considerably diminish the duration of the examination (from 3 to 4 hours to less than 1 hour).
- Conditions
- Myocardial Perfusion
- Being tested
- Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel), 99mTc-Sestamibi, Thallium-201
- Keywords
- 99mTc-Sestamibi, thallium-201, semiconductor camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel)Procedure or surgery
- During stress test, intravenous injection of 99mTc-Sestamibi (between 80 and 150 MBq according to weight) in patient
- Stress conventional acquisition with D.SPECT camera 20 min after injection
- 60 min after 99mTc-Sestamibi injection, rest injection of thallium-201 (50% activity of stress 99mTc-Sestamibi)
- double isotope acquisition 5 min after thallium-201 injection
- injection of 99mTc-Sestamibi at rest (activity 3 times higher), after 2 hours from first 99mTc-Sestamibi injection
- rest conventional acquisition 20 min later
99mTc-SestamibiDrug
First intravenous injection between 80 and 150 MBq according to patient weight and second injection with 3-time-higher activity, 2 hours after the first
For tomoscintigraphy
Thallium-201Drug
Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection)
For tomoscintigraphy
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with abnormalities of myocardial perfusion detected with stress tomoscintigraphy, undergo double isotope myocardial tomoscintigraphy using Thallium-201 and 99mTc-sestamibi and traditional myocardial tomoscintigraphy using 99mTc-sestamibi with a semiconductor camera Receives: Procedure: Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel); Drug: 99mTc-Sestamibi; Drug: Thallium-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
Bad; medium; good; very good
Measured: day 0
Nature of observed abnormalities obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
Without abnormalities or artefacts (normal); with rest reversible abnormalities (ischemia); with rest non reversible abnormalities (infarction)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial PerfusionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wassila DJABALLAH, Dr, Principal investigator, Service de Médecine Nucléaire, Hôpital de Brabois, 54511 Vandœuvre les Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869126
- Sponsor's protocol ID
- 2012-A00569-34
- Acronym
- D-SPECT BIS
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera
- ClinicalTrials.gov ID
- NCT02869126
- Acronym / sponsor ID
- D-SPECT BIS / 2012-A00569-34
- Conditions
- Myocardial Perfusion
- Keywords
- 99mTc-Sestamibi, thallium-201, semiconductor camera
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Aug 2016 (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 is to demonstrate the concordance of diagnostic information obtained with:
- a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later, and
- a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest, in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.
Detailed description
Myocardial perfusion tomoscintigraphy is very used for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion. This examination can be performed with semiconductor gamma cameras that are more performant than conventional cameras regarding spatial resolution, detection sensitivity and energy resolution.
The amelioration of energy resolution could allow the realization of simultaneous recordings of a dye injected at rest and another injected during stress (double isotope recording), while conventional examination needs 2 different recordings, stress and rest, separated from several hours.
In this study patients undergo a conventional examination with D.SPECT camera with 2 recordings, the first after injection of a little activity of 99mTc-sestamibi at stress (≤ 100 MBq) and the second, 2 hours later, after injection at rest of a 3 time bigger activity of 99mTc-sestamibi (≤ 300 MBq). An activity of thallium-201(≤ 50 MBq) is injected at rest after the first recording of stress. 5 minutes later, a supplementary double isotope recording is realized with D.SPECT camera (99mTc-Sestamibi-stress / thallium201-rest).
The demonstration of the hypothesis of this study could considerably diminish the duration of the examination (from 3 to 4 hours to less than 1 hour).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel), Drug: 99mTc-Sestamibi, Drug: Thallium-201Patients with abnormalities of myocardial perfusion detected with stress tomoscintigraphy, undergo double isotope myocardial tomoscintigraphy using Thallium-201 and 99mTc-sestamibi and traditional myocardial tomoscintigraphy using 99mTc-sestamibi with a semiconductor camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18, without guardianship, signed informed consent
- Without contraindication for myocardial perfusion tomoscintigraphy and stress technique (dipyridamole and/or effort), according to common criteria to French Societies of Cardiology and Nuclear Medicine, as it is requested for all patients needing this routine examination
- Not in life-and-death emergency, with a stable clinical state (without cardiac insufficiency or instable coronary, without hypertension not well-stabilized under treatment)
- Effective contraceptive method for women of childbearing potential
- Weight ≤ 100 kg (> 100 kg patients need higher injected activities in order to obtain adequate image quality)
Key exclusion criteria (8 listed)
- < 18
- Contraindications to stress test (effort and/or dipyridamole)
- Hypersensibility to thallium201 chloride or one of excipients
- Claustrophobic patient or incapable to stay lying down for 30 minutes
- Pregnancy or doubt of pregnancy
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 |
|---|---|---|
| Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel)* During stress test, intravenous injection of 99mTc-Sestamibi (between 80 and 150 MBq according to weight) in patient * Stress conventional acquisition with D.SPECT camera 20 min after injection * 60 min after 99mTc-Sestamibi injection, rest injection of thallium-201 (50% activity of stress 99mTc-Sestamibi) * double isotope acquisition 5 min after thallium-201 injection * injection of 99mTc-Sestamibi at rest (activity 3 times higher), after 2 hours from first 99mTc-Sestamibi injection * rest conventional acquisition 20 min later | Procedure or surgery | Patients |
| 99mTc-SestamibiFirst intravenous injection between 80 and 150 MBq according to patient weight and second injection with 3-time-higher activity, 2 hours after the first For tomoscintigraphy | Drug | Patients |
| Thallium-201Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection) For tomoscintigraphy | Drug | Patients |
Primary outcome
Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
Time frame: day 0
Bad; medium; good; very good
Nature of observed abnormalities obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
Time frame: day 0
Without abnormalities or artefacts (normal); with rest reversible abnormalities (ischemia); with rest non reversible abnormalities (infarction)
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 Aug 2016.
- Individual participant dataSharing planned: No
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Validation of Myocardial Perfusion and Extracellular Volume Assessment Using Photon-Counting Computed Tomography (PCCT) Compared With Cardiac Magnetic Resonance (CMR) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
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Enrolling by invitationObservational study
18F-MFBG Cardiac Imaging for Heart Failure Administration
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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.
Wassila DJABALLAH, Dr principal investigator
Service de Médecine Nucléaire, Hôpital de Brabois, 54511 Vandœuvre les Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel), 99mTc-Sestamibi and Thallium-201 in people with Myocardial Perfusion, run by Central Hospital, Nancy, France at 2 sites 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 6 inclusion and 8 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 16 Aug 2016. 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 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?
Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy (time frame: day 0). The study lists 2 primary outcomes in all. 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 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.