NCT02861235

Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Myocardial Infarction
• Ischemia

Interventions

Type	Name	Description
OTHER	Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary	with gamma-camera and D.SPECT camera
OTHER	Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day	with gamma-camera and D.SPECT camera, in Toulouse centre
OTHER	Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day	with gamma-camera and D.SPECT camera, in Nancy centre
OTHER	stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days	with gamma-camera and D.SPECT camera, in Paris centre
OTHER	Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera	rest thallium-201 tomoscintigraphy for myocardial viability assessment
OTHER	Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera	rest technetium-99m tomoscintigraphy for myocardial viability assessment

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2016-08-10
• Last updated: 2016-08-10

Locations

3 sites across 1 country: France