Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera (DSPECT)

Central Hospital, Nancy, France

Status: Completed

Conditions: Ischemia; Myocardial Infarction

Treatments: Other: Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera; Other: Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day; Other: stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days; Other: Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera; Other: Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary; Other: Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day

Study type: Interventional

Funder types: Other

Identifiers

NCT02861235

2009-A00422-55

Details and patient eligibility

About

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.

Full 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).

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 6 patient groups

1. stress thallium-201 tomoscintigraphy

Experimental group

Treatment:

Other: Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary

2. stress technetium-99m tomoscintigraphy 1

Experimental group

Treatment:

Other: Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day

3. stress technetium-99m tomoscintigraphy 2

Experimental group

Treatment:

Other: Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day

4. stress technetium-99m tomoscintigraphy 3

Experimental group

Treatment:

Other: stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days

5. rest thallium-201 tomoscintigraphy

Experimental group

Treatment:

Other: Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera

6. rest technetium-99m tomoscintigraphy

Experimental group

Treatment:

Other: Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera