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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Ischemia
• Interventions: Other: Rest thallium-201 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; 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

• Registration Number: NCT02861235
• Lead Sponsor: Central Hospital, Nancy, France

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).

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2016-07-29
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5. rest thallium-201 tomoscintigraphy	Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera	-
1. stress thallium-201 tomoscintigraphy	Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary	-
3. stress technetium-99m tomoscintigraphy 2	Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day	-
2. stress technetium-99m tomoscintigraphy 1	Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day	-
4. stress technetium-99m tomoscintigraphy 3	stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days	-
6. rest technetium-99m tomoscintigraphy	Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera	-

Primary Outcome Measures

Name	Time	Method
Telesystolic volume of link ventricle	day 0
Diagnosis of stress ischemia with Myocardial Tomoscintigraphy data	day 0
Telediastolic volume of link ventricle	day 0
Area of damaged regions of heart	day 0
Ejection fraction of link ventricle	day 0

Secondary Outcome Measures

Name	Time	Method
Global myocardial activity	day 0
Qualitative score of image quality	day 0

Trial Locations

Locations (3)

Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris; 🇫🇷 Paris, France

Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy; 🇫🇷 Vandoeuvre-les-Nancy, France

Service de Médecine Nucléaire, Clinique Louis Pasteur; 🇫🇷 Toulouse, France