Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera (DSPECT)
Primary Purpose
Myocardial Infarction, Ischemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary
Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day
Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day
stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days
Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera
Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Understanding and signature of informed consent
- Without any contraindication for tomoscintigraphy and stress techniques according to French Society of Cardiology and Nuclear Medicine criteria, as established for all patients doing this routine examination
- Not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment)
- Having an effective contraception for women of childbearing potential
Exclusion Criteria:
- Patient under guardianship
Sites / Locations
- Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris
- Service de Médecine Nucléaire, Clinique Louis Pasteur
- Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1. stress thallium-201 tomoscintigraphy
2. stress technetium-99m tomoscintigraphy 1
3. stress technetium-99m tomoscintigraphy 2
4. stress technetium-99m tomoscintigraphy 3
5. rest thallium-201 tomoscintigraphy
6. rest technetium-99m tomoscintigraphy
Arm Description
Outcomes
Primary Outcome Measures
Ejection fraction of link ventricle
Telesystolic volume of link ventricle
Telediastolic volume of link ventricle
Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data
Area of damaged regions of heart
Secondary Outcome Measures
Global myocardial activity
Qualitative score of image quality
Full Information
NCT ID
NCT02861235
First Posted
July 29, 2016
Last Updated
August 5, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02861235
Brief Title
Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
Acronym
DSPECT
Official Title
Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera According to Conditions of Examination Execution: Assessment of Infarction or Ischemia, Injected Dye and Sequence of Injections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. However, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. Only one pilot study has been recently published on this type of camera, the D.SPECT camera.
This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.
Detailed Description
This study will be conducted in Nuclear Medicine departments (Nancy Hospital, Bichat Hospital in Paris, Pasteur private hospital in Toulouse), with D.SPECT camera (Cyclopharma). The D.SPECT camera recording will be realized following the conventional camera recording and will not modify the routine programmed examination. Recording times of D.SPECT camera will be maximum 2 minutes for imaging with a strong activity of technetium-99m labeled dye and maximum 4 minutes for imaging with thallium-201 or with a low activity of technetium-99m labeled dye.6 study groups will be analyzed: 4 groups of patients initially doing stress tomoscintigraphy with thallium-201 (group 1) or with technetium-99m labeled dye and then testing 3 principal injection sequences (group 2, 3, 4), and 2 groups of patients initially doing "myocardial viability" assessment with rest tomoscintigraphy with thallium-201 (group 5) or technetium-99m labeled dye.
Recording comparison obtained with 2 cameras will be done according to qualitative and quantitative criteria on image quality and analyzing diagnosis concordance (presence, type and severity of observed abnormalities).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. stress thallium-201 tomoscintigraphy
Arm Type
Experimental
Arm Title
2. stress technetium-99m tomoscintigraphy 1
Arm Type
Experimental
Arm Title
3. stress technetium-99m tomoscintigraphy 2
Arm Type
Experimental
Arm Title
4. stress technetium-99m tomoscintigraphy 3
Arm Type
Experimental
Arm Title
5. rest thallium-201 tomoscintigraphy
Arm Type
Experimental
Arm Title
6. rest technetium-99m tomoscintigraphy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary
Intervention Description
with gamma-camera and D.SPECT camera
Intervention Type
Other
Intervention Name(s)
Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day
Intervention Description
with gamma-camera and D.SPECT camera, in Toulouse centre
Intervention Type
Other
Intervention Name(s)
Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day
Intervention Description
with gamma-camera and D.SPECT camera, in Nancy centre
Intervention Type
Other
Intervention Name(s)
stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days
Intervention Description
with gamma-camera and D.SPECT camera, in Paris centre
Intervention Type
Other
Intervention Name(s)
Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera
Intervention Description
rest thallium-201 tomoscintigraphy for myocardial viability assessment
Intervention Type
Other
Intervention Name(s)
Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera
Intervention Description
rest technetium-99m tomoscintigraphy for myocardial viability assessment
Primary Outcome Measure Information:
Title
Ejection fraction of link ventricle
Time Frame
day 0
Title
Telesystolic volume of link ventricle
Time Frame
day 0
Title
Telediastolic volume of link ventricle
Time Frame
day 0
Title
Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data
Time Frame
day 0
Title
Area of damaged regions of heart
Time Frame
day 0
Secondary Outcome Measure Information:
Title
Global myocardial activity
Time Frame
day 0
Title
Qualitative score of image quality
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Understanding and signature of informed consent
Without any contraindication for tomoscintigraphy and stress techniques according to French Society of Cardiology and Nuclear Medicine criteria, as established for all patients doing this routine examination
Not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment)
Having an effective contraception for women of childbearing potential
Exclusion Criteria:
Patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wassilia DJABALLAH
Organizational Affiliation
Service de Médecine Nucléaire, Hôpital de Brabois, 54500, Vandoeuvre-les-Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris
City
Paris
Country
France
Facility Name
Service de Médecine Nucléaire, Clinique Louis Pasteur
City
Toulouse
Country
France
Facility Name
Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy
City
Vandoeuvre-les-Nancy
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera
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