AngioscintigraphyFEVEDNCT02869308
Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy
A study testing stannous pyrophosphate, Technetium-99m and E-CAM Camera in people with Angioscintigraphy and Tomoscintigraphy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioscintigraphy, Tomoscintigraphy
- What is being tested?
- stannous pyrophosphate, Technetium-99m and E-CAM Camera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to May 2018
- 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
- Patients present in Nuclear Medicine department for measurement of LVEF by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy
- Without guardianship, signed informed consent
- Not in life-and-death emergency and with a stable clinical state
- Affiliated to social security
- Preliminary medical examination
Who cannot join
- Patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation)
- Incapable to stay in strict decubitus position during image recording times
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Gilles KARCHER, Pr contact
France1 site, 1 recruiting
- Recruiting
CHU de NANCY - Service de Médecine Nucléaire
Nancy
Gilles KARCHER, Pr
Olivier MOREL, Dr
About this study
Official title: Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy: Comparison Between Measurements Obtained With Conventional Planar Scintigraphy (E-CAM Camera) and Tomoscintigraphy Recorded by a CZT Semiconductor Camera (D-SPECT)
The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.
Secondary purposes are:
- To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
- To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).
Read the detailed description
Cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (LVEF). It needs injection of 99mTc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 MBq) for image recording times shorter than 10 minutes. This examination is thus quite irradiant (10 mSv) but this inconvenient could be eliminated with new semiconductor cameras.
These new cameras allow a better image quality than conventional Anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. However, these new cameras can record only 3D images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of LVEF measurement.
In this study, patients needing the routine examination for LVEF measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection).
If LVEF measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.
- Conditions
- Angioscintigraphy, Tomoscintigraphy
- Being tested
- stannous pyrophosphate, Technetium-99m, E-CAM Camera, CZT Semiconductor Camera (D-SPECT)
- Keywords
- Cardiomyopathy, Chemotherapy, Left ventricular ejection fraction
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stannous pyrophosphateDrug
Also called Angiocis
Injection of 1ml Angiocis
Technetium-99mDrug
Injection of 900 MBq Technetium-99m, 30 min after Angiocis injection
E-CAM CameraDevice
Acquisition of images of angioscintigraphy with E-CAM camera, after injection of Angiocis and Technetium-99m
CZT Semiconductor Camera (D-SPECT)Device
Acquisition of images of angioscintigraphy with D-SPECT camera
| Study group | Role | What they receive |
|---|---|---|
| Myocardial angioscintigraphy | Other | Not described Receives: Drug: stannous pyrophosphate; Drug: Technetium-99m; Device: E-CAM Camera; Device: CZT Semiconductor Camera (D-SPECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
Measured: day 0
Secondary outcomes (5)
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%
Measured: day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%
Measured: day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 75%
Measured: day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients having cardiomyopathies
Measured: day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapy
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 startJan 2014
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioscintigraphyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles KARCHER, Pr, Principal investigator, CHU de NANCY - Service de Médecine Nucléaire - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869308
- Sponsor's protocol ID
- 2013-A00650-45
- Acronym
- FEVED
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 17 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 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy: Comparison Between Measurements Obtained With Conventional Planar Scintigraphy (E-CAM Camera) and Tomoscintigraphy Recorded by a CZT Semiconductor Camera (D-SPECT)
- ClinicalTrials.gov ID
- NCT02869308
- Acronym / sponsor ID
- FEVED / 2013-A00650-45
- Conditions
- Angioscintigraphy, Tomoscintigraphy
- Keywords
- Cardiomyopathy, Chemotherapy, Left ventricular ejection fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- 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 determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.
Secondary purposes are:
- To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
- To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).
Detailed description
Cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (LVEF). It needs injection of 99mTc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 MBq) for image recording times shorter than 10 minutes. This examination is thus quite irradiant (10 mSv) but this inconvenient could be eliminated with new semiconductor cameras.
These new cameras allow a better image quality than conventional Anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. However, these new cameras can record only 3D images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of LVEF measurement.
In this study, patients needing the routine examination for LVEF measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection).
If LVEF measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial angioscintigraphy | Other | Drug: stannous pyrophosphate, Drug: Technetium-99m, Device: E-CAM Camera, Device: CZT Semiconductor Camera (D-SPECT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients present in Nuclear Medicine department for measurement of LVEF by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy
- Without guardianship, signed informed consent
- Not in life-and-death emergency and with a stable clinical state
- Affiliated to social security
- Preliminary medical examination
Key exclusion criteria (3 listed)
- Patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation)
- Incapable to stay in strict decubitus position during image recording times
- Pregnant or breastfeeding women
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 |
|---|---|---|
| stannous pyrophosphateAlso: AngiocisInjection of 1ml Angiocis | Drug | Myocardial angioscintigraphy |
| Technetium-99mInjection of 900 MBq Technetium-99m, 30 min after Angiocis injection | Drug | Myocardial angioscintigraphy |
| E-CAM CameraAcquisition of images of angioscintigraphy with E-CAM camera, after injection of Angiocis and Technetium-99m | Device | Myocardial angioscintigraphy |
| CZT Semiconductor Camera (D-SPECT)Acquisition of images of angioscintigraphy with D-SPECT camera | Device | Myocardial angioscintigraphy |
Primary outcome
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
Time frame: day 0
5 secondary outcomes
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%
Time frame: day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%
Time frame: day 0
Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 75%
Time frame: day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients having cardiomyopathies
Time frame: day 0
Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapy
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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.
Gilles KARCHER, Pr contact
Gilles KARCHER, Pr principal investigator
CHU de NANCY - Service de Médecine Nucléaire - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stannous pyrophosphate, Technetium-99m and E-CAM Camera in people with Angioscintigraphy and Tomoscintigraphy, run by Central Hospital, Nancy, France 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 5 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: status not confirmed, as of the sponsor's last update on 17 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles KARCHER, Pr (g.karcher@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person (time frame: day 0). 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 17 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.